Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized olaparib as a monotherapy for the maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.

This is written in the approval document as:

Lynparza is indicated as monotherapy for the maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.

Citation

AstraZeneca AB. Lynparza (olaparib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/lynparza-epar-product-information_en.pdf. Revised August 2024. Accessed August 25, 2024.

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Therapeutic response

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

Organization(s) Biomarker(s) Cancer type Therapy(ies)
EMA (1) BRCA1 oncogenic variants Ovarian Epithelial Tumor Olaparib
EMA (1) BRCA1 pathogenic variants Ovarian Epithelial Tumor Olaparib
EMA (1) BRCA2 oncogenic variants Ovarian Epithelial Tumor Olaparib
EMA (1) BRCA2 pathogenic variants Ovarian Epithelial Tumor Olaparib
EMA (1) BRCA1 oncogenic variants High-Grade Serous Fallopian Tube Cancer Olaparib
EMA (1) BRCA1 pathogenic variants High-Grade Serous Fallopian Tube Cancer Olaparib
EMA (1) BRCA2 oncogenic variants High-Grade Serous Fallopian Tube Cancer Olaparib
EMA (1) BRCA2 pathogenic variants High-Grade Serous Fallopian Tube Cancer Olaparib
EMA (1) BRCA1 oncogenic variants Peritoneal Serous Carcinoma Olaparib
EMA (1) BRCA1 pathogenic variants Peritoneal Serous Carcinoma Olaparib
EMA (1) BRCA2 oncogenic variants Peritoneal Serous Carcinoma Olaparib
EMA (1) BRCA2 pathogenic variants Peritoneal Serous Carcinoma Olaparib