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Ref Type
PMID
Authors
Title Kadclya (trastuzumab emtansine) FDA Drug Label
Journal
Vol
Issue
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URL https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125427
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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Ado-trastuzumab emtansine Ado-trastuzumab emtansine 44 23
Drug Name Trade Name Synonyms Drug Classes Drug Description
Ado-trastuzumab emtansine Kadcyla T-DM1|trastuzumab emtansine HER2 (ERBB2) Antibody 47 Kadcyla (ado-trastuzumab emtansine) is an antibody drug conjugate combined of the ERBB2 (HER2) monoclonal antibody, trastuzumab, and an anti-tubulin agent, DM1, which results in tumor cell cytotoxicity (PMID: 24887180). Kadcyla (ado-trastuzumab emtansine) is FDA approved for metastatic ERBB2 (HER2)-positive (overexpression or gene amplification) breast cancer patients who have previously received trastuzumab and/or taxane, and for the adjuvant treatment of patients with ERBB2 (HER2)-positive early breast cancer who have residual invasive disease after taxane and trastuzumab-based treatment (FDA.gov).
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
ERBB2 over exp Her2-receptor positive breast cancer sensitive Ado-trastuzumab emtansine FDA approved - On Companion Diagnostic Actionable In a Phase III trial (EMILIA) that supported FDA approval, treatment with Kadclya (trastuzumab emtansine) improved median progression free survival (9.6 mo vs 6.4 mo) and overall survival (30.9 mo vs 25.1 mo) compared to Tykerb (lapatinib) combined with Xeloda (capecitabine) in patients with metastatic ERBB2 (HER2)-positive breast cancer (PMID: 24879797, PMID: 23020162; NCT00829166). 24879797 detail... detail... 23020162
ERBB2 amp Her2-receptor positive breast cancer sensitive Ado-trastuzumab emtansine FDA approved - On Companion Diagnostic Actionable In a Phase III trial (EMILIA) that supported FDA approval, treatment with Kadclya (trastuzumab emtansine) improved median progression free survival (9.6 mo vs 6.4 mo) and overall survival (30.9 mo vs 25.1 mo) compared to Tykerb (lapatinib) combined with Xeloda (capecitabine) in patients with metastatic ERBB2 (HER2)-positive breast cancer (PMID: 24879797, PMID: 23020162; NCT00829166). 24879797 23020162 detail... detail...
ERBB2 amp Her2-receptor positive breast cancer sensitive Ado-trastuzumab emtansine FDA approved - On Companion Diagnostic Actionable In a Phase III trial (KATHERINE) that supported FDA approval, treatment with Kadclya (trastuzumab emtansine) resulted in improved invasive disease-free survival (HR=0.50, p<0.001) compared to Herceptin (trastuzumab) in patients with ERBB2 (HER2)-positive early breast cancer who had residual invasive disease after taxane and trastuzumab-based neoadjuvant therapy (PMID: 30516102; NCT01772472). detail... detail... 30516102
ERBB2 over exp Her2-receptor positive breast cancer sensitive Ado-trastuzumab emtansine FDA approved - On Companion Diagnostic Actionable In a Phase III trial (KATHERINE) that supported FDA approval, treatment with Kadclya (trastuzumab emtansine) resulted in improved invasive disease-free survival (HR=0.50, p<0.001) compared to Herceptin (trastuzumab) in patients with ERBB2 (HER2)-positive early breast cancer who had residual invasive disease after taxane and trastuzumab-based neoadjuvant therapy (PMID: 30516102; NCT01772472). detail... detail... 30516102