List of Anti-Cancer Drugs Aproved by the FDA _ PharmaKnow

Drug Drug Trade Name Approved Use Manufacturer/DistributorApproval

Date

abarelix Plenaxis depot

For the palliativetreatment of men withadvanced symptomaticprostate cancer, inwhom LHRH agonisttherapy is notappropriate and whorefuse surgicalcastration, and have oneor more of the following:(1) risk of neurologicalcompromise due tometastases, (2) ureteralor bladder outletobstruction due to localencroachment ormetastatic disease, or (3)severe bone pain fromskeletal metastasespersisting on narcoticanalgesia

PraecisNov 252003

aldesleukin ProkineTreatment of adults withmetastatic melanoma

ChironJan 091998

Aldesleukin ProleukinTreatment of adults withmetastatic renal cellcarcinoma

Chiron CorpMay 051992

Alemtuzumab Campath

Accel. Approv. (clinicalbenefit not established)Campath is indicated forthe treatment of B-cellchronic lymphocyticleukemia (B-CLL) inpatients who have beentreated with alkylatingagents and who havefailed fludarabinetherapy.

Millennium and ILEXPartners, LP

May 072001

alitretinoin Panretin

Topical treatment ofcutaneous lesions inpatients withAIDS-related Kaposi’ssarcoma.

Ligand PharmaceuticalsFeb 021999

allopurinol Zyloprim

Patients with leukemia,lymphoma and solidtumor malignancies whoare receiving cancertherapy which causeselevations of serum andurinary uric acid levelsand who cannot tolerateoral therapy.

GlaxoSmithKlineMay 171996

Single agent palliativetreatment of patients

List of Anti-Cancer Drugs Aproved By the FDA | PharmaKnow.com http://pharmaknow.com/list-of-anti-cancer-drugs-aproved-by-the-fda/

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oral therapy.

altretamine Hexalen

Single agent palliativetreatment of patientswith persistent orrecurrent ovarian cancerfollowing first-linetherapy with a cisplatinand/or alkylating agentbased combination.

US BioscienceDec 261990

amifostine Ethyol

To reduce thecumulative renal toxicityassociated with repeatedadministration ofcisplatin in patients withadvanced ovarian cancer

US BioscienceDec 081995

amifostine Ethyol

Accel. Approv. (clinicalbenefit not established)Reduction of platinumtoxicity in non-small celllung cancer

US BioscienceMar 151996

amifostine Ethyol

To reduce post-radiationxerostomia for head andneck cancer where theradiation port includes asubstantial portion of theparotid glands.

US BioscienceJun 241999

anakinra Kineret

pediatric Use section ofthe US product label andto fulfill PMC #3 toassess the safety andefficacy of anakinra inpediatric patients withjuvenile rheumatoidarthritis

AmgenDec 152006

anastrozole Arimidex

Accel. Approv. (clinicalbenefit not established)for the adjuvanttreatment ofpostmenopausal womenwith hormone receptorpositive early breastcancer

AstraZenecaSep 052002


Conversion to regularapproval for theadjuvant treatment ofpostmenopausal womenwith hormone receptorpositive early breastcancer

AstraZenecaSep 162005


Treatment of advancedbreast cancer inpostmenopausal womenwith disease progressionfollowing tamoxifentherapy

AstraZenecaPharmaceuticals

Dec 271995


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anastrozole Arimidexp pwith disease progressionfollowing tamoxifentherapy.

Pharmaceuticals 1995


For first-line treatmentof postmenopausalwomen with hormonereceptor positive orhormone receptorunknown locallyadvanced or metastaticbreast cancer.


Sep 012000

arsenic trioxide Trisenox

Second line treatment ofrelapsed or refractoryAPL following ATRAplus an anthracycline.

Cell TherapeuticSep 252000

asparaginase ElsparTherapy of patients withacute lymphocyticleukemia

MerckJan 101978

Asparaginase Elspar

ELSPAR is indicated inthe therapy of patientswith acute lymphocyticleukemia. This agent isuseful primarily incombination with otherchemotherapeutic agentsin the induction ofremissions of the diseasein pediatric patients.

Merck & Co, IncAug 012002

azacitidine Vidaza

For use for the treatmentof patients with thefollowingmyelodysplasticsyndrome subtypes:refractory anemia orrefractory anemia withringed sideroblasts (ifaccompanied byneutropenia orthrombocytopenia andrequiring transfusions),refractory anemia withexcess blasts, refractoryanemia with excessblasts in transformation,and chronicmyelomonocyticleukemia

PharmionMay 192004

indicated for treatmentof patients with thefollowingmyelodysplasticsyndrome subtypes:refractory anemia orrefractory anemia withi d id bl (if


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azacitidine Vidaza

syndrome subtypes:refractory anemia orrefractory anemia withringed sideroblasts (ifaccompanied byneutropenia orthrombocytopenia orrequiring transfusions),refractory anemia withexcess blasts, refractoryanemia with excessblasts in transformation,and chronicmyelomonocyticleukemia.

PharmionJan 262007

BCG Live TICE BCG Organon Teknika CorpAug 211998

bevacizumab AvastinMetastatic coloncarcinoma

GenentechJun 202006

bevacizumab Avastin

FDA approved changedin the Avastin packageinsert regarding warningand dose andadministration forReversible PosteriorLeukoencephalopathySyndrome. Nasal septumperforation was alsoadded as a seriousadverse event.

GenentechSep 212006

bevacizumab Avastin

a first-line treatment ofpatients with locallyadvanced, metastatic orrecurrent non-small celllung cancer incombination withplatinum-basedchemotherapy

GenentechOct 112006

bevacuzimab Avastin

First-line treatment ofpatients with metastaticcarcinoma of the colonand rectum (incombination withintravenous5-fluorouracil-basedchemotherapy)

GenentechFeb 262004

bexarotene capsules Targretin

For the treatment by oralcapsule of cutaneousmanifestations ofcutaneous T-celllymphoma in patientswho are refractory to atleast one prior systemictherapy.

Ligand PharmaceuticalsDec 291999

For the topical treatment


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least one prior systemictherapy.

bexarotene gel Targretin

For the topical treatmentof cutaneousmanifestations ofcutaneous T-celllymphoma in patientswho are refractory to atleast one prior systemictherapy.

Ligand PharmaceuticalsJun 282000

bleomycin Blenoxane Bristol-Myers SquibbJul 311973

bleomycin Blenoxane

Sclerosing agent for thetreatment of malignantpleural effusion (MPE)and prevention ofrecurrent pleuraleffusions.

Bristol-Myers SquibbFeb 201996

bortezombi Velcade

for the treatment ofpatients with mantle celllymphoma who havereceived at least oneprior therapy

MillenniumDec 082006

bortezomib Velcade

Accel. Approv. (clinicalbenefit not established)for the treatment ofmultiple myelomapatients who havereceived at least twoprior therapies and havedemonstrated diseaseprogression on the lasttherapy

MilleniumMay 132003

bortezomib Velcade

Conversion to regularapproval for treatmentof multiple myelomapatients who havereceived as least oneprior therapy

MilleniumMar 252005

busulfan intravenous Busulfex

Use in combination withcyclophoshamide asconditioning regimenprior to allogeneichematopoieticprogenitor celltransplantation forchronic myelogenousleukemia.

Orphan Medical, IncFeb 041999

busulfan oral MyleranChronic MyelogenousLeukemia- palliativetherapy

GlaxoSmithKlineJun 261954

calusterone MethosarbPharmacia & UpjohnCompany

Feb 201973

Accel. Approv. (clinical


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calusterone MethosarbPharmacia & UpjohnCompany

Feb 201973

capecitabine Xeloda

Accel. Approv. (clinicalbenefit subsequentlyestablished) Treatmentof metastatic breastcancer resistant to bothpaclitaxel and ananthracycline containingchemotherapy regimenor resistant to paclitaxeland for whom furtheranthracycline therapymay be contraindicated,e.g., patients who havereceived cumulativedoses of 400 mg/m2 ofdoxorubicin ordoxorubicin equivalents

RocheApr 301998

capecitabine Xeloda

Initial therapy ofpatients with metastaticcolorectal carcinomawhen treatment withfluoropyrimidine therapyalone is preferred.Combinationchemotherapy hasshown a survival benefitcompared to 5-FU/LValone. A survival benefitover 5_FU/LV has notbeen demonstrated withXeloda monotherapy.

RocheApr 302001

capecitabine Xeloda

Conversion to regularapproval for treatment incombination withdocetaxel of patientswith metastatic breastcancer after failure ofprior anthracyclinecontainingchemotherapy

RocheSep 072001

capecitabine Xeloda

Adjuvant treatment inpatients with Dukes’ Ccolon cancer who haveundergone completeresection of the primarytumor when treatmentwith fluoropyrimidinetherapy alone ispreferred

RocheJun 152005

carboplatin Paraplatin

Palliative treatment ofpatients with ovariancarcinoma recurrentafter prior

Bristol-Myers SquibbMar 03


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patients with ovariancarcinoma recurrentafter priorchemotherapy, includingpatients who have beenpreviously treated withcisplatin.

Bristol-Myers SquibbMar 031989


Initial chemotherapy ofadvanced ovariancarcinoma incombination with otherapprovedchemotherapeuticagents.

Bristol-Myers SquibbJul 051991

carmustine BCNU, BiCNU Bristol-Myers SquibbMar 071977

carmustine Gliadel

Treatment of patientswith malignant gliomaundergoing primarysurgical resection

MGI PharmaFeb 252003

carmustine withPolifeprosan 20Implant

Gliadel Wafer

For use in addition tosurgery to prolongsurvival in patients withrecurrent glioblastomamultiforme who qualifyfor surgery.

Guilford PharmaceuticalsInc.

Sep 231996

celecoxib Celebrex

Accel. Approv. (clinicalbenefit not established)Reduction of polypnumber in patients withthe rare genetic disorderof familial adenomatouspolyposis.

SearleDec 231999

cetuximab Erbitux

Accel. Approv. (clinicalbenefit not established)for treatment ofEGFR-expressingmetastatic colorectalcarcinoma in patientswho are refractory toirinotecan-basedchemotherapy (incombination withirinotecan); as a singleagent, treatment ofEGFR-expressingmetastatic colorectalcarcinoma in patientswho are intolerant toirinotecan-basedchemotherapy

ImcloneFeb 122004

For use in combinationwith radiation therapy(RT) for the treatment oflocally or regionally


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cetuximab Erbitux

with radiation therapy(RT) for the treatment oflocally or regionallyadvanced squamous cellcarcinoma of the headand neck (SCCHN) or asa single agent for thetreatment of patientswith recurrent ormetastatic SCCHN forwhom priorplatinum-based therapyhas failed.

ImcloneMar 012006

chlorambucil Leukeran GlaxoSmithKlineMar 181957

cisplatin Platinol

Metastatic testicular-inestablished combinationtherapy with otherapprovedchemotherapeutic agentsin patients withmetastatic testiculartumors whoc havealready receivedappropriate surgicaland/or radiotherapeuticprocedures. Anestablished combinationtherapy consists ofPlatinol, Blenoxane andVelbam.

Bristol-Myers SquibbDec 191978

cisplatin Platinol

Metastatic ovariantumors - in establishedcombination therapywith other approvedchemotherapeuticagents: Ovarian-inestablished combinationtherapy with otherapprovedchemotherapeutic agentsin patients withmetastatic ovariantumors who havealready receivedappropriate surgicaland/or radiotherapeuticprocedures. Anestablished combinationconsists of Platinol andAdriamycin. Platinol, asa single agent, isindicated as secondarytherapy in patients withmetastatic ovarian



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indicated as secondarytherapy in patients withmetastatic ovariantumors refractory tostandard chemotherapywho have not previouslyreceived Platinoltherapy.

cisplatin Platinol

as a single agent forpatients with transitionalcell bladder cancerwhich is no longeramenable to localtreatments such assurgery and/orradiotherapy.

Bristol-Myers SquibbApr 221993

cladribine Leustatin, 2-CdATreatment of activehairy cell leukemia.

R.W. JohnsonPharmaceutical ResearchInstitute

Feb 261993

clofarabine Clolar

Accel. Approv. (clinicalbenefit not established)for the treatment ofpediatric patients 1 to 21years old with relapsedor refractory acutelymphoblastic leukemiaafter at least two priorregimens

GenzymeDec 282004

cyclophosphamide Cytoxan, Neosar Bristol-Myers SquibbNov 161959

cyclophosphamide Cytoxan Injection Bristol-Myers SquibbNov 161959

cyclophosphamide Cytoxan Injection Bristol-Myers SquibbApr 291987

cyclophosphamide Cytoxan Tablet Bristol-Myers SquibbApr 291987

cytarabine Cytosar-UPharmacia & UpjohnCompany

Jun 171969

cytarabine liposomal DepoCyt

Accel. Approv. (clinicalbenefit not established)Intrathecal therapy oflymphomatousmeningitis

Skye PharmaceuticalsApr 011999

dacarbazine DTIC-Dome BayerMay 271975

dactinomycin,actinomycin D

Cosmegen MerckFeb 041964

dactinomycin,actinomycin D

Cosmegan MerckDec 101964

provides for the use ofFragmin (dalteparinsodium injection) forextended treatment ofsymptomatic venous


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dalteparin sodium Fragmin

g ( psodium injection) forextended treatment ofsymptomatic venousthromboembolism (VTE)[proximal deep veinthrombosis (DVT)and/or pulmonaryembolism (PE)] toreduce the recurrence ofVTE in patients withcancer.

Pharmacia & UpjohnMay 012007

darbepoetin alfa Aranesp

for the treatment ofanemia associated withchronic renal failure,including patients ondialysis and patients noton dialysis, and for thetreatment of anemia inpatients withnon-myeloidmalignancies whereanemia is due to theeffect of concomitantlyadministeredchemotherapy.

AmgenMar 092007

darbepoetin alfa Aranesp AmgenApr 102007

Darbepoetin alfa AranespTreatment of anemiaassociated with chronicrenal failure.

Amgen, IncSep 172001

Darbepoetin alfa Aranesp

Aranesp is indicated forthe treatment of anemiain patients with non-myeloid malignancieswhere anemia is due tothe effect ofconcomitantlyadministeredchemotherapy.

Amgen, IncJul 192002

dasatinib SprycelChronic myelogenousleukemia

Bristol Myers SquibbJun 282006

daunorubicin liposomal DanuoXome

First line cytotoxictherapy for advanced,HIV related Kaposi’ssarcoma.

Nexstar, Inc.Apr 081996

daunorubicin,daunomycin

Daunorubicin

Leukemia/myelogenous/monocytic/erythroid ofadults/remissioninduction in acutelymphocytic leukemia ofchildren and adults.

Bedford LabsJan 301998


Cerubidine

In combination withapproved anticancerdrugs for induction of

Wyeth AyerstMar 111987


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Cerubidine

In combination withapproved anticancerdrugs for induction ofremission in adult ALL.

Wyeth AyerstMar 111987

decitabine Dacogen

for the treatment ofpatients withmyelodysplasticsyndromes (MDS)including previouslytreated and untreated, denovo and secondaryMDS of all French-American-Britishsubtypes (refractoryanemia, refractoryanemia with ringedsideroblasts, refractoryanemia with excessblasts, refractory anemiawith excess blasts intransformation, andchronic myelomonocyticleukemia) andintermediate-1,intermediate-2, andhigh-risk InternationalPrognostic ScoringSystem groups.

MGI PHARMA INCMay 052006

denileukin Ontak Seragen

Denileukin diftitox Ontak

Accel. Approv. (clinicalbenefit not established)treatment of patientswith persistent orrecurrent cutaneousT-cell lymphoma whosemalignant cells expressthe CD25 component ofthe IL-2 receptor

Seragen, IncFeb 051999

dexrazoxane Zinecard

Accel. Approv. (clinicalbenefit subsequentlyestablished) Preventionof cardiomyopathyassociated withdoxorubicinadministration

Pharmacia & UpjohnCompany

May 261995


Conversion to regularapproval for reducingthe incidence andseverity ofcardiomyopathyassociated withdoxorubicinadministration in womenwith metastatic breastcancer who have Pharmacia & Upjohn Oct 31


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administration in womenwith metastatic breastcancer who havereceived a cumulativedoxorubicin dose of 300mg/m2 and who willcontinue to receivedoxorubicin therapy tomaintain tumor control.It is not recommendedfor use with theinitiation of doxorubicintherapy.


Oct 312002

docetaxel Taxotere

Accel. Approv. (clinicalbenefit subsequentlyestablished) Treatmentof patients with locallyadvanced or metastaticbreast cancer who haveprogressed duringanthracycline-basedtherapy or have relapsedduringanthracycline-basedadjuvant therapy.

Aventis PharmaceuticalMay 141996

docetaxel Taxotere

Conversion to regularapproval - treatment oflocally advanced ormetastatic breast cancerwhich has progressedduringanthracycline-basedtreatment or relapsedduringanthracycline-basedadjuvant therapy.

Aventis PharmaceuticalJun 221998

docetaxel Taxotere

For locally advanced ormetastatic non-small celllung cancer after failureof prior platinum-basedchemotherapy.

Aventis PharmaceuticalDec 231999

docetaxel Taxotere

for use in combinationwith cisplatin for thetreatment of patientswith unresectable,locally advanced ormetastatic non-small celllung cancer who havenot previously receivedchemotherapy for thiscondition cisplatin forthe treatment of patientswith unresectable,locally advanced ormetastatic non-small cell

Aventis PharmaceuticalNov 272002


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with unresectable,locally advanced ormetastatic non-small celllung cancer who havenot previously receivedchemotherapy for thiscondition.

docetaxel Taxotere

For use in combinationwith prednisone as atreatment for patientswith androgenindependent (hormonerefractory) metastaticprostate cancer

Aventis PharmaceuticalMay 192004

docetaxel Taxotere

For use in combinationwith doxorubicin andcyclophosphamide forthe adjuvant treatmentof patients with operablenodepositive breastcancer

Aventis PharmaceuticalAug 182004

docetaxel Taxotere

for use in combinationwith cisplatin andfluorouracil for theinduction treatment ofpatients with inoperable,locally advancedsquamous cellcarcinoma of the headand neck.

Sanofi AventisOct 172006

doxorubicin Adriamycin PFS

For use in combinationwith cyclophosphamideas a component ofadjuvant therapy inpatients with evidenceof axillary node tumorinvolvement followingresection of primarybreast cancer

PharmaciaMay 082003

doxorubicin Adriamycin, RubexPharmacia & UpjohnCompany

Aug 071974

doxorubicinAdriamycin PFSInjectionintravenousinjection

Antibiotic, antitumoragent.


Dec 231987

doxorubicin liposomal Doxil

Conversion to regularapproval for treatmentof patients with ovariancancer whose diseasehas progressed orrecurred afterplatinum-basedchemotherapy

AlzaJan 282005

Accel. Approv. (clinicalbenefit not established)Treatment of


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Accel. Approv. (clinicalbenefit not established)Treatment ofAIDS-related Kaposi’ssarcoma in patients withdisease that hasprogressed on priorcombinationchemotherapy or inpatients who areintolerant to suchtherapy.

Sequus Pharmaceuticals,Inc.

Nov 171995


Accel. Approv. (clinicalbenefit not established)Treatment of metastaticcarcinoma of the ovaryin patient with diseasethat is refractory to bothpaclitaxel and platinumbased regimens

Sequus Pharmaceuticals,Inc.

Jun 281999

DROMOSTANOLONEPROPIONATE

DROMOSTANOLONE Eli LillyOct 261961

DROMOSTANOLONEPROPIONATE

MASTERONEINJECTION

SYNTEXOct 081964

eculizumab Soliris

for the treatment ofparoxysmal nocturnalhemoglobinuria (PNH)to reduce hemolysis.

AlexionMar 162007

Elliott’s B Solution Elliott’s B Solution

Diluent for theintrathecaladministration ofmethotrexate sodiumand cytarabine for theprevention or treatmentof meningeal leukemiaor lymphocyticlymphoma.

Orphan Medical, IncSep 271996

epirubicin Ellence

A component ofadjuvant therapy inpatients with evidenceof axillary node tumorinvolvement followingresection of primarybreast cancer.


Sep 151999

epirubicin hcl epirubicin hcl

as a component ofadjuvant therapy inpatients with evidenceof axillary node tumorinvolvement followingresection of primarybreast cancer.

MayneSep 152006

is indicated for thetreatment of anemiarelated to therapy with


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epoetin alfa Epogen/Procrit

is indicated for thetreatment of anemiarelated to therapy withzidovudine inHIV-infected patients.EPOGEN® is indicatedto elevate or maintainthe red blood cell level(as manifested by thehematocrit orhemoglobindeterminations) and todecrease the need fortransfusions in thesepatients. EPOGEN® isnot indicated for thetreatment of anemia inHIV-infected patientsdue to other factors suchas iron or folatedeficiencies, hemolysis,or gastrointestinalbleeding, which shouldbe managedappropriately.

AmgenMar 092007

Epoetin alfa epogen

EPOGENB is indicatedfor the treatment ofanemia in patients withnon-myeloidmalignancies whereanemia is due to theeffect of concomitantlyadministeredchemotherapy.EPOGEND is indicatedto decrease the need fortransfusions in patientswho will be receivingconcomitantchemotherapy for aminimum of 2 months.EPOGENB is notindicated for thetreatment of anemia incancer patients due toother factors such asiron or folatedeficiencies, hemolysisor gastrointestinalbleeding, which shouldbe managedappropriately.


EPOGENB is indicatedfor the reatment ofanemia related totherapy with zidovudine


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Epoetin alfa epogen

EPOGENB is indicatedfor the reatment ofanemia related totherapy with zidovudinein HIV- infectedpatients. EPOGENB isindicated to elevate ormaintain the red bloodcell level (as manifestedby the hematocrit orhemoglobindeterminations) and todecrease the need fortransfusions in thesepatients. EPOGEND isnot indicated for thetreatment of anemia inHIV-infected patientsdue to other factors suchas iron or folatedeficiencies, hemolysisor gastrointestinalbleeding, which shouldbe managedappropriately.


Epoetin alfa epogen

EPOGENB is indicatedfor the treatment ofanemic patients(hemoglobin > 10 to _<13 g/dL) scheduled toundergo elective,noncardiac, nonvascularsurgery to reduce theneed for allogeneicblood transfusions.


Epoetin alfa epogen

EPOGEN is indicatedfor the treatment ofanemia associated withCRF, including patientson dialysis (ESRD) andpatients not on dialysis.

Amgen, InchJul 261999

erlotinib Tarceva

For treatment of locallyadvanced or metastaticNon Small-Cell LungCancer (NSCLC) afterfailure of at least oneprior chemotherapyregimen

OSINov 182004

erlotinib Tarceva

For use in combinationwith gemcitabine for thefirst-line treatment ofpatients with locallyadvanced, unresectableor metastatic pancreaticcancer

OSINov 022005

lli ti f t t Ph i & U j h D 24


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,or metastatic pancreaticcancer

estramustine Emcytpalliation of prostatecancer


Dec 241981

etoposide phosphate Etopophos

Management ofrefractory testiculartumors, in combinationwith other approvedchemotherapeuticagents.

Bristol-Myers SquibbMay 171996


Management of smallcell lung cancer,first-line, in combinationwith other approvedchemotherapeuticagents.

Bristol-Myers SquibbMay 171996


Management ofrefractory testiculartumors and small celllung cancer.


etoposide, VP-16 Vepesid

Refractory testiculartumors-in combinationtherapy with otherapprovedchemotherapeutic agentsin patients withrefractory testiculartumors who havealready receivedappropriate surgical,chemotherapeutic andradiotherapeutictherapy.

Bristol-Myers SquibbNov 101983

etoposide, VP-16 VePesid

In combination withother approvedchemotherapeutic agentsas first line treatment inpatients with small celllung cancer.


etoposide, VP-16 Vepesid

In combination withother approvedchemotherapeutic agentsas first line treatment inpatients with small celllung cancer.


exemestane Aromasin

For adjuvant treatmentof postmenopausalwomen with estrogen-receptor positive earlybreast cancer who havereceived two to threeyears of tamoxifen andare switched toAROMASIN® for

PharmaciaOct 052005


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exemestane Aromasin years of tamoxifen andare switched toAROMASIN® forcompletion of a total offive consecutive years ofadjuvant hormonaltherapy

Pharmacia2005

exemestane Aromasin

Treatment of advancebreast cancer inpostmenopausal womenwhose disease hasprogressed followingtamoxifen therapy.


Oct 211999

fentanyl citrate Fentora

for the management ofbreakthrough pain inpatients with cancer whoare already receivingand who are tolerant toopioid therapy for theirunderlying persistentcancer pain.

CephalonSep 252006

Filgrastim Neupogen

Decrease incidence ofinfection in patients withnonmyeloidmalignancies

Amgen, IncFeb 201991

Filgrastim Neupogen

NEUPOGEN isindicated to decrease theincidence of infection‚as manifested by febrileneutropenia‚ in patientswith nonmyeloidmalignancies receivingmyelosuppressiveanticancer drugsassociated with asignificant incidence ofsevere neutropenia withfever.

Amgen, IncApr 021998

Filgrastim Neupogen

NEUPOGEN isindicated for reducingthe time to neutrophilrecovery and theduration of fever,following induction orconsolidationhemotherapy treatmentof adults with AML.


Filgrastim Neupogen

NEUPOGEN isindicated to reduce theduration of neutropeniaand neutropenia-relatedclinical sequelae, eg,febrile neutropenia, inpatients withnonmyeloid



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Filgrastim Neupogenfebrile neutropenia, inpatients withnonmyeloidmalignancies undergoingmyeloablativechemotherapy followedby marrowtransplantation.


floxuridine(intraarterial)

FUDR RocheDec 181970

fludarabine Fludara

Palliative treatment ofpatients with B-celllymphocytic leukemia(CLL) who have notresponded or haveprogressed duringtreatment with at leastone standard alkylatingagent containingregimen.

Berlex Laboratories Inc.Apr 181991

fluorouracil, 5-FU Adrucilprolong survival incombination withleucovorin

ICN Puerto RicoApr 251962

fulvestrant Faslodex

the treatment ofhormone receptor-positive metastaticbreast cancer inpostmenopausal womenwith disease progressionfollowing antiestrogentherapy

IPRApr 252002

gefitinib Iressa

Accel. Approv. (clinicalbenefit not established )as monotherapy for thetreatment of patientswith locally advanced ormetastatic non-small celllung cancer after failureof both platinum-basedand docetaxelchemotherapies

AstraZencaMay 052003

gemcitabine Gemzar

Treatment of patientswith locally advanced(nonresectable stage IIor III) or metastatic(stage IV)adenocarcinoma of thepancreas. Indicated forfirst-line treatment andfor patients previouslytreated with a5-fluorouracil-containingregimen.

Eli LillyMay 151996

For use in combinationith i l ti f th


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gregimen.

gemcitabine Gemzar

For use in combinationwith cisplatin for thefirst-line treatment ofpatients with inoperable,locally advanced (StageIIIA or IIIB) ormetastatic (Stage IV)non-small cell lungcancer.

Eli LillyAug 251998

gemcitabine hcl Gemzar Ovarian cancer LillyJul 142006

gemicitabine Gemzar

For use in combinationwith paclitaxel for thefirst-line treatment ofpatients with metastaticbreast cancer afterfailure of prioranthracycline-containingadjuvant chemotherapy,unless anthracyclineswere clinicallycontraindicated

LillyMay 192004

gemtuzumabozogamicin

Mylotarg

Accel. Approv. (clinicalbenefit not established)Treatment of CD33positive acute myeloidleukemia in patients infirst relapse who are 60years of age or older andwho are not consideredcandidates for cytotoxicchemotherapy.

Wyeth AyerstMay 172000

goserelin acetate ZoladexAstraZenecaPharmaceuticals

Dec 181995

goserelin acetate Zoladex Implant

Palliative treatment ofadvanced breast cancerin pre- andperimenopausal women.


Dec 181995

histrelin acetate Histrelin implantFor the palliativetreatment of advancedprostate cancer

ValeraOct 122004

hydroxyurea Hydrea Bristol-Myers SquibbDec 071967

hydroxyurea HydreaDecrease need fortransfusions in sickle cellanemia


Ibritumomab Tiuxetan Zevalin

Accel. Approv. (clinicalbenefit not established)treatment of patientswith relapsed orrefractory low-grade,follicular, or transformedB cell non Hodgkin’s

IDEC PharmaceuticalsCorp

Feb 192002


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Ibritumomab Tiuxetan Zevalin

prefractory low-grade,follicular, or transformedB-cell non-Hodgkin’slymphoma, includingpatients with Rituximabrefractory follicularnon-Hodgkin’slymphoma.

IDEC PharmaceuticalsCorp

Feb 192002

idarubicin Idamycin

For use in combinationwith other approvedantileukemic drugs forthe treatment of acutemyeloid leukemia(AML) in adults.

Adria LaboratoriesSep 271990

idarubicin Idamycin

In combination withother approvedantileukemic drugs forthe treatment of acutenon-lymphocyticleukemia in adults.


Feb 171997

ifosfamide IFEX

Third line chemotherapyof germ cell testicularcancer when used incombination with certainother approvedantineoplastic agents.


imatinib mesylate Gleevec

Accel. Approv. (clinicalbenefit not established)Initial therapy of chronicmyelogenous leukemia

NovartisMay 102001


Accel. Approv. (clinicalbenefit not established)metastatic orunresectable malignantgastrointestinal stromaltumors

NovartisFeb 012002

Imatinib mesylate Gleevec

Accel. Approv. (clinicalbenefit not established)Treatment of patientswith Kit (CD117)positive unresectableand/or metastaticmalignantgastrointestinal stromaltumors (GIST).

NovartisFeb 012002


Accel. Approv. (clinicalbenefit not established)Initial treatment ofnewly diagnosed Ph+chronic myelogenousleukemia (CML).

NovartisDec 202002

Accel. Approv. (clinicalbenefit not established)for treatment of newly


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Accel. Approv. (clinicalbenefit not established)for treatment of newlydiagnosed adult patientswith Philadelphiachromosome positivechronic myeloidleukemia (CML) inchronic phase.Follow-up is limited.Gleevec is also indicatedfor the treatment ofpatients withPhiladelphiachromosome positivechronic myeloidleukemia (CML) in blastcrisis, accelerated phase,or in chronic phase afterfailure ofinterferon-alpha therapy.There are no controlledtrials demonstrating aclinical benefit, such asimprovement in disease-related symptoms orincreased survival inpatients with CML blastcrisis, accelerated phaseor chronic phase afterfailure of alphainterferon. Gleevec isalso indicated for thetreatment of patientswith Kit (CD117)positive unresectableand/or metastaticmalignantgastrointestinal stromaltumors (GIST)

NovartisApr 182003


Accel. Approv. (clinicalbenefit not established)Treatment of pediatricpatients with Ph+chronic phase CMLwhose disease hasrecurred after stem celltransplant or who areresistant to interferonalpha therapy.

NovartisMay 202003


Conversion to regularapproval for treatmentof patients withPhiladelphiachromosome positivechronic myeloid Novartis

Dec 08


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pPhiladelphiachromosome positivechronic myeloidleukemia (CML) in blastcrisis, accelerated phase,or in chronic phase afterfailure ofinterferon-alpha therapy

NovartisDec 082003


for the treatment ofpediatric patients withnewly diagnosedPhiladelphiachromosome positivechronic myelogenousleukemia (Ph+ CML).

NovartisSep 272006

imatinib mesylate Gleevecsingle agent for thetreatment of multipleindications

NovartisOct 192006

interferon alfa 2a Roferon ATreatment of patientswith hairy cell leukemia

RocheJun 041986

interferon alfa 2a Roferon A

Chronic phase,Philadelphiachromosome positivechronic myelogenousleukemia (CML)patients who areminimally pretreated(within 1 year ofdiagnosis)

RocheOct 191995

Interferon alfa-2a Roferon-A Hoffmann-La Roche IncNov 011996

Interferon alfa-2b Intron A

Interferon alfa-2b,recombinant forInjection is indicated forthe treatment of patients18 years of age or olderwith hairy cell leukemia.

Schering CorpJun 041986


Interferon alfa-2b,recombinant forInjection is indicated forintralesional treatmentof selected patients 18years of age or olderwith condylomataacuminata involvingexternal surfaces of thegenital and perianalareas.

Schering CorpJun 061988

Interferon alfa-2b,recombinant forinjection is indicated forthe treatment of selectedpatients 18 years of ageor older with


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the treatment of selectedpatients 18 years of ageor older withAIDS-related Kaposi’sSarcoma. The likelihoodof response to INTRONA therapy is greater inpatients who are withoutsystemic symptoms, whohave limitedlymphadenopathy andwho have a relativelyintact immune system asindicated by total CD4count.

Schering CorpNov 211988


Interferon alfa-2b,recombinant forinjection is indicated asadjuvant to surgicaltreatment in patients 18years of age or olderwith malignantmelanoma who are freeof disease but at highrisk for systemicrecurrence within 56days of surgery.

Schering CorpDec 051995


Interferon alfa-2b,recombinant forInjection is indicated forthe initial treatment ofclinically aggressivefollicular non-Hodgkin’sLymphoma inconjunction withanthracycline-containingcombinationchemotherapy inpatients 18 years of ageor older.

Schering CorpNov 061997

Interferon alfa-2b Intron A Intron A Schering CorpJun 212002

irinotecan Camptosar

Accel. Approv. (clinicalbenefit subsequentlyestablished) Treatmentof patients withmetastatic carcinoma ofthe colon or rectumwhose disease hasrecurred or progressedfollowing 5-FU-basedtherapy.


Jun 141996

Conversion to regularapproval - treatment ofmetastatic carcinoma of


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Conversion to regularapproval - treatment ofmetastatic carcinoma ofthe colon or rectumwhose disease hasrecurred or progressedfollowing 5-FU-basedtherapy.


Oct 221998


For first line treatment ncombination with5-FU/leucovorin ofmetastatic carcinoma ofthe colon or rectum.


Apr 202000

lapatinib ditosylate Tykerb

for use in combinationwith capecitabine for thetreatment of patientswith advanced ormetastatic breast cancerwhose tumorsoverexpress HER2(ErbB2) and who havereceived prior therapyincluding ananthracycline, a taxane,and trastuzumab.

SmithKline BeechamMar 132007

lapatinib ditosylate Tykerb SmithKline BeechamApr 272007

lenalidomide Revlimid Multiple myeloma CelegeneJun 292006

lenalidomide Revlimid

for the treatment ofpatients withtransfusion-dependentanemia due to Low- orIntermediate-1-riskmyelodysplasticsyndromes associatedwith a deletion 5qcytogenetic abnormalitywith or withoutadditional cytogeneticabnormalities

CelgeneDec 272005

letrozole FemaraTreatment of advancedbreast cancer inpostmenopausal women.

NovartisJul 251997

letrozole Femara

First-line treatment ofpostmenopausal womenwith hormone receptorpositive or hormonereceptor unknownlocally advanced ormetastatic breast cancer.

NovartisJan 102001

letrozole Femara NovartisJan 172003

Accel. Approv. (clinical


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letrozole Femara NovartisJan 172003

letrozole Femara

Accel. Approv. (clinicalbenefit not established)for the extendedadjuvant treatment ofearly breast cancer inpostmenopausal womenwho have received fiveyears of adjuvanttamoxifen therapy.

NovartisOct 292004

leucovorinWellcovorin,Leucovorin

Leucovorin calcium isindicated fro use incombination with5-fluorouracil to prolongsurvival in the palliativetreatment of patientswith advancedcolorectal cancer.

Immunex CorporationJun 201952

leucovorin Leucovorin Immunex CorporationJan 301987

leucovorin Leucovorin Immunex CorporationJan 301987

leucovorin Leucovorin Immunex CorporationAug 311988

leucovorin Leucovorin

In combination withfluorouracil to prolongsurvival in the palliativetreatment of patientswith advancedcolorectal cancer.

Lederle LaboratoriesDec 121991

Leuprolide Acetate Eligardpalliative treatment ofadvanced prostatecancer.

QLT USAJan 232002

levamisole Ergamisol

Adjuvant treatment incombination with5-fluorouracil aftersurgical resection inpatients with Dukes’Stage C colon cancer.

Janssen ResearchFoundation

Jun 181990

lomustine, CCNU CeeBU Bristol-Myers SquibbAug 041976

meclorethamine,nitrogen mustard

Mustargen MerckMar 151949

megestrol acetate Megace Bristol-Myers SquibbAug 181971

melphalan, L-PAM Alkeran GlaxoSmithKlineJan 171964

melphalan, L-PAM Alkeran

Systemic administrationfor palliative treatmentof patients with multiplemyeloma for whom oraltherapy is notappropriate.

GlaxoSmithKlineNov 181992


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melphalan, L-PAM Alkeranmyeloma for whom oraltherapy is notappropriate.

GlaxoSmithKline1992

mercaptopurine, 6-MP Purinethol GlaxoSmithKlineSep 111953

mesna MesnexPrevention ofifosfamide-inducedhemorrhagic cystitis

Asta MedicaDec 301988

mesna Mesnex tabsReducing the incidenceof ifosfamide-inducedhemorrhagic cystitis

BaxterMar 212002

methotrexate Methotrexate Lederle LaboratoriesDec 071953

methotrexate Methotrexate Lederle LaboratoriesAug 101959

methotrexate Methotrexate Lederle LaboratoriesNov 011971

methotrexate Methotrexate Lederle LaboratoriesNov 011971

methotrexate Methotrexate osteosarcoma Lederle LaboratoriesApr 071988

methotrexate Methotrexate Lederle LaboratoriesOct 311988

methoxsalen Uvadex

For the use of UVADEXwith the UVARPhotopheresis System inthe palliative treatmentof the skinmanifestations ofcutaneous T-celllymphoma (CTCL) thatis unresponsive to otherforms of treatment.

TherakosFeb 251999

mitomycin C Mutamycin Bristol-Myers SquibbMay 281974

mitomycin C Mitozytrex

therapy of disseminatedadenocarcinoma of thestomach or pancreas inproven combinationswith other approvedchemotherapeutic agentsand as palliativetreatment when othermodalities have failed.

SupergenNov 142002

mitotane Lysodren Bristol-Myers SquibbJul 081970

mitoxantrone Novantrone

For use in combinationwith corticosteroids asinitial chemotherapy forthe treatment of patientswith pain related toadvanced hormone-refractory prostate

Immunex CorporationNov 131996


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with pain related toadvanced hormone-refractory prostatecancer.

p1996

mitoxantrone Novantrone

For use with otherapproved drugs in theinitial therapy for acutenonlymphocyticleukemia (ANLL) inadults.

Lederle LaboratoriesDec 231987

nandrolonephenpropionate

Durabolin-50 OrganonOct 301959

nelarabine Arranon

Accel. Approv. (clinicalbenefit not established)for the treatment ofpatients with T-cellacute lymphoblasticleukemia and T-celllymphoblasticlymphoma whosedisease has notresponded to or hasrelapsed followingtreatment with at leasttwo chemotherapyregimens

GlaxoSmithKlineOct 282005

Nofetumomab VerlumaBoehringer IngelheimPharma KG (formerly Dr.Karl Thomae GmbH)

Aug 201996

Oprelvekin Neumega

Prevention of severethrombocytopeniafollowingmyelosuppressivechemotherapy

Genetics Institute, IncNov 251997

Oprelvekin Neumega Genetics Institute, IncSep 182002

Oprelvekin Neumega

Neumega is indicated forthe prevention of severethrombocytopenia andthe reduction of theneed for platelettransfusions followingmyelosuppressivechemotherapy in adultpatients withnonmyeloidmalignancies who are athigh risk of severethrombocytopenia.

Genetics Institute, IncSep 182002

oprelvekin Neumega

warnings regardingophthalmologic andventricular arrhythmiasadverse events havebeen added to theoprelvekin (Neumega)

WyethSep 132006


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oprelvekin Neumegay

adverse events havebeen added to theoprelvekin (Neumega)label

WyethSep 132006

oxaliplatin Eloxatin

Accel. Approv. (clinicalbenefit not established)in combination withinfusional 5-FU/LV, isindicated for thetreatment of patientswith metastaticcarcinoma of the colonor rectum whose diseasehas recurred orprogressed during orwithin 6 months ofcompletion of first linetherapy with thecombination of bolus5-FU/LV and irinotecan.

Sanofi SynthelaboAug 092002


Conversion to regularapproval for use incombination withinfusional 5-Fluorouracil(5-FU) and Leucovorin(LV) for the treatment ofpatients previouslyuntreated for advancedcolorectal cancer

Sanofi SynthelaboJan 092004


for use in combinationwith infusional 5-FU/LV,for the adjuvanttreatment of stage IIIcolon cancer patientswho have undergonecomplete resection ofthe primary tumor

Sanofi SynthelaboNov 042004

paclitaxel Abraxane

for the treatment ofbreast cancer afterfailure of combinationchemotherapy formetastatic disease orrelapse within 6 monthsof adjuvantchemotherapy. Priortherapy should haveincluded ananthracycline unlessclinicallycontraindicated.

AbraxisFeb 152007

paclitaxel Paxene

treatment of advancedAIDS-related Kaposi’ssarcoma after failure offirst line or subsequentsystemic chemotherapy

Baker NortonPharmaceuticals, Inc

Dec 241997


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paclitaxel PaxeneS e ed pos s

sarcoma after failure offirst line or subsequentsystemic chemotherapy

Baker NortonPharmaceuticals, Inc

Dec 241997

paclitaxel Taxol

Treatment of patientswith metastaticcarcinoma of the ovaryafter failure of first-lineor subsequentchemotherapy.


paclitaxel Taxol

Treatment of breastcancer after failure ofcombinationchemotherapy formetastatic disease orrelapse within 6 monthsof adjuvantchemotherapy. Priortherapy should haveincluded ananthracycline unlessclinicallycontraindicated.


paclitaxel Taxol

New dosing regimen forpatients who have failedinitial or subsequentchemotherapy formetastatic carcinoma ofthe ovary

Bristol-Myers SquibbJun 221994

paclitaxel Taxolsecond line therapy forAIDS related Kaposi’ssarcoma.

Bristol-Myers SquibbAug 041997

paclitaxel Taxol

For first-line therapy forthe treatment ofadvanced carcinoma ofthe ovary in combinationwith cisplatin.


paclitaxel Taxol

for use in combinationwith cisplatin, for thefirst-line treatment ofnon-small cell lungcancer in patients whoare not candidates forpotentially curativesurgery and/or radiationtherapy.


paclitaxel Taxol

For the adjuvanttreatment ofnode-positive breastcancer administeredsequentially to standarddoxorubicin-containingcombination therapy.

Bristol-Myers SquibbOct 251999

paclitaxel TaxolFirst line ovarian cancerwith 3 hour infusion.



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combination therapy.

paclitaxel TaxolFirst line ovarian cancerwith 3 hour infusion.


paclitaxelprotein-bound particles

Abraxane

For the treatment ofbreast cancer afterfailure of combinationchemotherapy formetastatic disease orrelapse within 6 monthsof adjuvantchemotherapy. Priortherapy should haveincluded an anthracylineunless clinicallycontraindicated

AM BioscienceJan 072005

palifermin Kepivance

Decrease the incidenceand duration of severeoral mucositis in patientswith hematologicmalignancies receivingmyelotoxic therapyrequiring hematopoeticstem cell support

AmgenDec 152004

pamidronate Aredia

Treatment of osteolyticbone metastases ofbreast cancer inconjunction withstandard antineoplastictherapy.

NovartisSep 221998

panitumumab Vectibixto treat metastaticcolorectal carcinoma

AmgenSep 272006

pegademaseAdagen (PegademaseBovine)

Enzyme replacementtherapy for patients withsevere combinedimmunodeficiency asaresult of adenosinedeaminase deficiency.

EnzonMar 211990

pegaspargase OncasparAcute lymphoblasticleukemia

EnzonJul 242006

pegaspargase Oncaspar

Acute lymphocyticleukemia inL-asparaginasehypersensitive patients

Enzon, IncFeb 011994

Pegfilgrastim Neulasta

Neulasta is indicated todecrease the incidenceof infection, asmanifested by febrileneutropenia, in patientswith non-myeloidmalignancies receivingmyelosuppressiveanti-cancer drugsassociated with aclinically significanti id f f b il

Amgen, IncJan 312002


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anti-cancer drugsassociated with aclinically significantincidence of febrileneutropenia.

Peginterferon alfa-2b PegIntrontrade name fromPEG-Intron to PegIntron

ScheringDec 222006

pemetrexed disodium Alimta

For use in the treatmentof patients withmalignant pleuralmesothelioma whosedisease is eitherunresectable or who areotherwise not candidatesfor curative surgery

LillyFeb 042004

pemetrexed disodium Alimta

Accel. Approv. (clinicalbenefit not established)as a single agent for thetreatment of patientswith locally advanced ormetastatic non-smalllung cancer after priorchemotherapy

LillyAug 192004

pentostatin Nipent

Single agent treatmentfor adult patients withalpha interferonrefractory hairy cellleukemia.

Parke-DavisPharmaceutical Co.

Oct 111991

pentostatin Nipent

Single-agent treatmentfor untreated hairy cellleukemia patients withactive disease as definedby clinically significantanemia, neutropenia,thrombocytopenia, ordisease-relatedsymptoms. (Supplementfor front -line therapy.)

Parke-DavisPharmaceutical Co.

Sep 291993

pipobroman Vercyte Abbott LabsJul 011966

plicamycin,mithramycin

Mithracin Pfizer LabsMay 051970

porfimer sodium Photofrin

For the ablation ofhigh-grade dysplasia inBarrett’s esophaguspatients who do notundergo esophagectomy

Axcan ScandipharmAug 012003


For use in photodynamictherapy (PDT) forpalliation of patientswith completelyobstructing esophagealcancer, or patients withpartially obstructingesophageal cancer who

QLT Phototherapeutics Inc.Dec 271995


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porfimer sodium Photofring p g

cancer, or patients withpartially obstructingesophageal cancer whocannot be satisfactorilytreated with ND-YAGlaser therapy.



For use in photodynamictherapy for treatment ofmicroinvasiveendobronchial nonsmallcell lung cancer inpatients for whomsurgery and radiotherapyare not indicated.

QLT Phototherapeutics Inc.Jan 091998


For use in photodynamictherapy (PDT) forreduction of obstructionand palliation ofsymptoms in patientswith completely orpartially obstructingendobroncial nonsmallcell lung cancer(NSCLC).


procarbazine Matulane Sigma Tau PharmsJul 221969

quinacrine Atabrine Abbott LabsDec 071964

Rasburicase Elitek

ELITEK is indicated forthe initial managementof plasma uric acidlevels in pediatricpatients with leukemia,lymphoma, and solidtumor malignancies whoare receiving anti-cancertherapy expected toresult in tumor lysis andsubsequent elevation ofplasma uric acid.

Sanofi-Synthelabo, IncJul 122002

rituximab Rituxan

for the first-linetreatment of patientswith low grade orfollicular, CD20-positiveB-cell non-Hodgkin’slymphoma.

GenentechSep 292006

rituximab Rituxan

for the first-linetreatment of patientswith low grade orfollicular, CD20-positiveB-cell non-Hodgkin’slymphoma.

GenentechSep 292006

Treatment of patientswith relapsed or


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lymphoma.

Rituximab Rituxan

Treatment of patientswith relapsed orrefractory low-grade orfollicular B-cellnon-Hodgkin’slymphoma

Genentech, IncNov 261997

Rituximab Rituxannon-Hodgkin’slymphoma

Genentech, IncFeb 102006

sargramostim Leukine

Acceleration of myeloidrecovery followingautologous bone marrowtransplant in patientswith non-Hodgkin’slymphoma, acutelymphocytic leukemia,or Hodgkin’s disease

BerlexMar 051991

Sargramostim Prokine Immunex CorpNov 071996

sorafenib NexavarFor the treatment ofpatients with advancedrenal cell carcinoma

BayerDec 202005

streptozocin Zanosar Antineoplastic agent.Pharmacia & UpjohnCompany

May 071982

sunitinib Sutent

for the treatment ofgastrointestinal stromaltumor after diseaseprogression on orintolerance to imatinibmesylate; for thetreatment of advancedrenal cell carcinoma.

CP PharmaceuticalsFeb 022007

sunitinib maleate Sutent

treatment ofgastrointestinal stromaltumor after diseaseprogression on orintolerance to imatinibmesylate

PfizerJan 262006

sunitinib maleate Sutent

Accel. Approv. (clinicalbenefit not established)for the treatment ofadvanced renal cellcarcinoma. Approval foradvanced renal cellcarcinoma is based onpartial response ratesand duration ofresponses. There are norandomized trials ofSUTENT demonstratingclinical benefit such asincreased survival orimprovement in disease-related symptoms in

l ll i

PfizerJan 262006


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increased survival orimprovement in disease-related symptoms inrenal cell carcinoma.

talc Sclerosol

For the prevention of therecurrence of malignantpleural effusion insymptomatic patients.

BryanDec 241997

tamoxifen NolvadexAstraZenecaPharmaceuticals

Dec 301977

tamoxifen Nolvadex

As a single agent todelay breast cancerrecurrence followingtotal mastectomy andaxillary dissection inpostmenopausal womenwith breast cancer(T1-3, N1, M0)


Dec 031986

tamoxifen Nolvadex

For use inpremenopausal womenwith metastatic breastcancer as an alternativeto oophorectomy orovarian irradiation


Mar 161989

tamoxifen Nolvadex

For use in women withaxillary node-negativebreast cancer adjuvanttherapy.


Jun 211990

tamoxifen NolvadexMetastatic breast cancerin men.


Apr 011993

tamoxifen Nolvadex

Equal bioavailability ofa 20 mg Nolvadex tablettaken once a day to a 10mg Nolvadex tablettaken twice a day.


Mar 211994

tamoxifen Nolvadex

to reduce the incidenceof breast cancer inwomen at high risk forbreast cancer


Oct 291998

tamoxifen Nolvadex

In women with DCIS,following breast surgeryand radiation, Nolvadexis indicated to reducethe risk of invasivebreast cancer.


Jun 292000

temozolomide Temodar

Accel. Approv. (clinicalbenefit not established)Treatment of adultpatients with refractoryanaplastic astrocytoma,i.e., patients at firstrelapse with diseaseprogression on anitrosourea and

b i t i i

ScheringAug 111999


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relapse with diseaseprogression on anitrosourea andprocarbazine containingregimen

temozolomide Temodar

Conversion to regularapproval for thetreatment of patientswith newly diagnosedhigh grade gliomasconcomitantly withradiotherapy and then asadjuvant treatment

ScheringMar 152005

teniposide, VM-26 Vumon

In combination withother approvedanticancer agents forinduction therapy inpatients with refractorychildhood acutelymphoblastic leukemia(all).

Bristol-Myers SquibbJul 141992

testolactone Teslac Bristol-Myers SquibbJun 031969

testolactone Teslac Bristol-Myers SquibbMay 271970

thalidomide Thalomid Multiple myeloma CelgeneMay 262006

thioguanine, 6-TG Thioguanine GlaxoSmithKlineJan 181966

thiotepa Thioplex Immunex CorporationMar 091959

thiotepa Thioplex Immunex CorporationDec 221994

thiotepa Thioplex Lederle LaboratoriesAug 151990

topotecan Hycamtin

Treatment of patientswith metastaticcarcinoma of the ovaryafter failure of initial orsubsequentchemotherapy.

GlaxoSmithKlineMay 281996

topotecan Hycamtin

Treatment of small celllung cancer sensitivedisease after failure offirst-line chemotherapy.In clinical studiessubmitted to supportapproval, sensitivedisease was defined asdisease responding tochemotherapy butsubsequently progressingat least 60 days (in thephase 3 study) or at least90 d (i h h 2



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subsequently progressingat least 60 days (in thephase 3 study) or at least90 days (in the phase 2studies) afterchemotherapy

topotecan hcl Hycamtin Cervical carcinoma GlaxoSmithKlineJun 142006

toremifene FarestonTreatment of advancedbreast cancer inpostmenopausal women.

Orion Corp.May 291997

Tositumomab Bexxar

Accel. Approv. (clinicalbenefit not established)Treatment of patientswith CD20 positive,follicular, non-Hodgkin’slymphoma, with andwithout transformation,whose disease isrefractory to Rituximaband has relapsedfollowing chemotherapy

Corixa CorporationJun 272003

Tositumomab/I-131tositumomab

Bexxar

Expand the indication toinclude patients withrelapsed or refractorylow grade folliculartransformedCD20-positivenon-Hodgkin’slymphoma who have notreceived rituximab

GlaxoSmithKlineDec 222004

trastuzumab HerceptinEarly Stage BreastCancer After PrimaryTherapy

GenentechNov 162006

Trastuzumab Herceptin

HERCEPTIN as a singleagent is indicated for thetreatment of patientswith metastatic breastcancer whose tumorsoverexpress the HER2protein and who havereceived one or morechemotherapy regimensfor their metastaticdisease.

Genentech, IncSep 251998

Trastuzumab Herceptin

Herceptin incombination withpaclitaxel is indicatedfor treatment of patientswith metastatic breastcancer whose tumorsoverexpress the HER-2protein and had notreceived chemotherapyfor their metastatic

Genentech, IncFeb 092000


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protein and had notreceived chemotherapyfor their metastaticdisease

Trastuzumab Herceptin Genentech, IncAug 282002

Trastuzumab Herceptin Genentech, IncAug 282002

tretinoin, ATRA Vesanoid

Induction of remission inpatients with acutepromyelocytic leukemia(APL) who arerefractory to or unableto tolerate anthracyclinebased cytotoxicchemotherapeuticregimens.

RocheNov 221995

Uracil MustardUracil MustardCapsules

Roberts LabsSep 131962

valrubicin Valstar

For intravesical therapyof BCG-refractorycarcinoma in situ (CIS)of the urinary bladder inpatients for whomimmediate cystectomywould be associatedwith unacceptablemorbidity or mortality.

Anthra –> MedevaSep 251998

vinblastine Velban Eli LillyNov 051965

vincristine Oncovin Eli LillyJul 101963







vinorelbine Navelbine

Single agent or incombination withcisplatin for the first-linetreatment of ambulatorypatients withunresectable, advancednon-small cell lungcancer (NSCLC).

GlaxoSmithKlineDec 231994

Navelbine is indicated as


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non-small cell lungcancer (NSCLC).

vinorelbine Navelbine

Navelbine is indicated asa single agent or incombination withcisplatin for the first-linetreatment of ambulatorypatients withunreseactable, advancednon-small cell lungcancer (NSCLC). Inpatients with Stage IVNSCLC, Navelbine isindicated as a singleagent or in combinationwith cisplatin. In StageIII NSCLC, Navelbine isindicated in combinationwith cisplatin.


vorinostat Zolinza

for the treatment ofcutaneousmanifestations ofcutaneous T-celllymphoma (CTCL) inpatients withprogressive, persistent,or recurrent disease onor following twosystemic therapies.

MerckOct 062006

zoledronate Zometa

the treatment of patientswith multiple myelomaand patients withdocumented bonemetastases from solidtumors, in conjunctionwith standardantineoplastic therapy.Prostate cancer shouldhave progressed aftertreatment with at leastone hormonal therapy

NovartisFeb 222002

zoledronic acid ZometaTreatment ofhypercalcemia ofmalignancy

NovartisAug 202001


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List of Anti-Cancer Drugs Aproved by the FDA _ PharmaKnow

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