Therapy Areas: Oncology
AstraZeneca's Lynparza receives US approval for BRCA-mutated prostate cancer
1 June 2023 -

Biopharmaceutical company AstraZeneca plc (STO:AZN) (LON:AZN) (Nasdaq:AZN) announced on Thursday that it has received US approval for Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC).

Lynparza is being jointly developed and commercialised by AstraZeneca and Merck & Co Inc (NYSE:MRK), known as MSD outside the US and Canada.

The US Food and Drug Administration (FDA) approval was based on data from the Phase III PROpel trial which showed significant improvements in radiographic progression-free survival (rPFS) and overall survival (OS) compared to abiraterone alone in patients with BRCA mutations. Patients treated with Lynparza plus abiraterone saw a 76% reduction in the risk of disease progression or death versus abiraterone alone.

Prostate cancer is the second-most common cancer in men, and the prognosis for patients with BRCA mutations is typically poor.

Lynparza is already approved in the US as monotherapy for patients with homologous recombination repair (HRR) gene-mutated mCRPC (BRCAm and other HRR gene mutations) who have progressed following prior treatment with enzalutamide or abiraterone; and in the EU, Japan and China for patients with BRCAm mCRPC who have progressed following prior therapy that included a new hormonal agent.

AstraZeneca will receive a regulatory milestone payment from MSD as a result of this approval.