Kadcyla

Product manufactured by Genentech, Inc.

Application Nr Approved Date Route Status External Links
BLA125427 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Kadcyla Is A Her2-Targeted Antibody And Microtubule Inhibitor Conjugate Indicated, As A Single Agent, For: The Treatment Of Patients With Her2-Positive, Metastatic Breast Cancer Who Previously Received Trastuzumab And A Taxane, Separately Or In Combination. Patients Should Have Either: Received Prior Therapy For Metastatic Disease, Or Developed Disease Recurrence During Or Within Six Months Of Completing Adjuvant Therapy. ( 1.1 ) The Adjuvant Treatment Of Patients With Her2-Positive Early Breast Cancer Who Have Residual Invasive Disease After Neoadjuvant Taxane And Trastuzumab-Based Treatment. ( 1.2 ) Select Patients For Therapy Based On An Fda-Approved Companion Diagnostic For Kadcyla [See Dosage And Administration (2.1) ] 1.1 Metastatic Breast Cancer (Mbc) Kadcyla ® , As A Single Agent, Is Indicated For The Treatment Of Patients With Her2-Positive, Metastatic Breast Cancer Who Previously Received Trastuzumab And A Taxane, Separately Or In Combination. Patients Should Have Either: Received Prior Therapy For Metastatic Disease, Or Developed Disease Recurrence During Or Within Six Months Of Completing Adjuvant Therapy. Select Patients For Therapy Based On An Fda-Approved Companion Diagnostic For Kadcyla [ See Dosage And Administration (2.1) ]. 1.2 Early Breast Cancer (Ebc) Kadcyla, As A Single Agent, Is Indicated For The Adjuvant Treatment Of Patients With Her2-Positive Early Breast Cancer Who Have Residual Invasive Disease After Neoadjuvant Taxane And Trastuzumab -Based Treatment. Select Patients For Therapy Based On An Fda-Approved Companion Diagnostic For Kadcyla [ See Dosage And Administration (2.1) ].

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Ado-Trastuzumab Emtansine

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