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PMID
Authors
Title Perjeta (pertuzumab) FDA Drug Label
Journal
Vol
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Date
URL https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125409
Abstract Text

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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
Pertuzumab Pertuzumab 8 9
Drug Name Trade Name Synonyms Drug Classes Drug Description
Pertuzumab Perjeta 2C4 Antibody HER2 (ERBB2) Antibody 47 Perjeta (pertuzumab) is a monoclonal antibody that binds ERBB2 (HER2) to prevent dimerization and subsequent HER signaling, thereby resulting in apoptosis and tumor growth inhibition (PMID: 15699478). Perjeta (pertuzumab) is FDA approved in combination with Herceptin (trastuzumab) and Taxotere (docetaxel) for patients with ERBB2 (HER2)-positive breast cancer and in combination with Herceptin (trastuzumab) and chemotherapy as neoadjuvant treatment for patients with ERBB2 (HER2)-positive breast cancer (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 amp Her2-receptor positive breast cancer sensitive Docetaxel + Pertuzumab + Trastuzumab FDA approved - On Companion Diagnostic Actionable In a Phase III trial (CLEOPATRA) that supported FDA approval, treatment with Perjeta (pertuzumab), combined with Herceptin (trastuzumab) and Taxotere (docetaxel), improved median progression free survival to 18.5 months compared to 12.4 months with placebo plus Herceptin (trastuzumab) and Taxotere (docetaxel) in patients with ERBB2 (HER2)-positive (overexpression and amplification) metastatic breast cancer (PMID: 23602601; NCT00567190). 23602601 detail... detail...
ERBB2 over exp Her2-receptor positive breast cancer sensitive Docetaxel + Pertuzumab + Trastuzumab FDA approved - On Companion Diagnostic Actionable In a Phase III trial (CLEOPATRA) that supported FDA approval, treatment with Perjeta (pertuzumab), combined with Herceptin (trastuzumab) and Taxotere (docetaxel), improved median progression free survival to 18.5 months compared to 12.4 months with placebo plus Herceptin (trastuzumab) and Taxotere (docetaxel) in patients with ERBB2 (HER2)-positive (overexpression and amplification) metastatic breast cancer (PMID: 23602601; NCT00567190). detail... 23602601 detail...