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DrugTreatmentofMetastaticBreastCancerDrugsapprovedforMetastaticBreastCancerPaclitaxel1994Docetaxel1996Trastuzumab1998Capecitabine1998Capecitabine+Docetaxel2001Abraxane2005Lapatinib2006Ixabepilone2007PaclitaxelPaclitaxel135mg/m23-hourinfusionTAXOLEfficacyResultsFullApprovalDocetaxelDocetaxelAcceleratedApproval1996Mytomicin12mg/m2Q6weeksVinblastine6mg/m2Q3weeksTAX304EfficacyResultsFullApprovalTrastuzumabTrastuzumab4mg/kgloadingdose2mg/kgwklymaintenanceHerceptinmonotherapyFullApprovalCapecitabineCapecitabinemonotherapyAcceleratedApprovalCapecitabineDocetaxel100mg/m2Q3weeksCapecitabineEfficacyResultsFullApprovalOverallSurvivalLapatinibCapecitabine2500mg/m2dailyfor14daysLapatinibEfficacyResultsFullApprovalEfficacyofCombinationTherapy:Kaplan-MeierCurvesofTTPIxabepiloneCapecitabine1250mg/m2BIDDays1to14q21daysIxabepiloneEfficacyResultsFullApprovalEfficacyofCombinationTherapy:Kaplan-MeierCurvesofPFSIxabepiloneSingle-armMonotherapyStudies(n=126)1stlineMetastaticBreastCancerDrugsapprovedin1stlineMetastaticBreastCancerTrastuzumabChemotherapyAloneHerceptinFullApprovalSurvivalAllPatientsGemcitabinePaclitaxel175mg/m2Days1and8q21daysSurvivalENDPOINTSSurvival:Basisofcytotoxicdrugapprovalin1stlineMBCEfficacyReasonsforusingSurvivalasbasisofapprovalin1stlineMBCSurvivalasabasisofapproval:ExamplesCross-overtherapyconfoundssurvivaleffect:truthormyth?SUMMARYSeeODACtranscriptforMondayJune7,1999,postedontheFDAwebsiteTTPasthebasisofapproval:ExamplesProgressionFreeSurvivalProblemswithPFSNDAsubmissionsbasedonPFSwillaffectsurvivaldata
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