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 germline BRCA1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen.

This is written in the approval document as:

Lynparza is indicated as monotherapy for the maintenance treatment of adult patients with germline BRCA1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen.

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.

Therapeutic response

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

Organization(s) Biomarker(s) Cancer type Therapy(ies)
EMA (1) BRCA1 pathogenic variants Pancreatic Adenocarcinoma Olaparib
EMA (1) BRCA2 pathogenic variants Pancreatic Adenocarcinoma Olaparib