Regulatory approval

Published by the Food and Drug Administration. Approved

Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.

This is written in the approval document.

Citation

AstraZeneca Pharmaceuticals, LP. Lynparza (olaparib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208558s028lbl.pdf. Revised November 2023. Accessed October 30, 2024.

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Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations Biomarkers Cancer types Therapies
FDA (1) BRCA1 oncogenic variants Ovarian Epithelial Tumor Olaparib
FDA (1) BRCA1 pathogenic variants Ovarian Epithelial Tumor Olaparib
FDA (1) BRCA2 oncogenic variants Ovarian Epithelial Tumor Olaparib
FDA (1) BRCA2 pathogenic variants Ovarian Epithelial Tumor Olaparib
FDA (1) BRCA1 oncogenic variants High-Grade Serous Fallopian Tube Cancer Olaparib
FDA (1) BRCA1 pathogenic variants High-Grade Serous Fallopian Tube Cancer Olaparib
FDA (1) BRCA2 oncogenic variants High-Grade Serous Fallopian Tube Cancer Olaparib
FDA (1) BRCA2 pathogenic variants High-Grade Serous Fallopian Tube Cancer Olaparib
FDA (1) BRCA1 oncogenic variants Peritoneal Serous Carcinoma Olaparib
FDA (1) BRCA1 pathogenic variants Peritoneal Serous Carcinoma Olaparib
FDA (1) BRCA2 oncogenic variants Peritoneal Serous Carcinoma Olaparib
FDA (1) BRCA2 pathogenic variants Peritoneal Serous Carcinoma Olaparib