Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that BRCA1 pathogenic variants status confers therapeutic sensitivity to Olaparib in patients with Pancreatic Adenocarcinoma.

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 statement is based on a regulatory approval from the European Medicines Agency:

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.

Contributions

Date Contributor Description
2024-10-20 Van Allen lab Adding EMA approvals for use to database
2020-07-03 European Medicines Agency Indication received approval from the European Commission.