Policy & Regulation
AstraZeneca reports Lynparza granted FDA Priority Review
16 August 2022 -

Pharmaceutical company AstraZeneca plc (STO:AZN) (LON:AZN) (Nasdaq:AZN) said on Tuesday that Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone has been granted Priority Review in the US for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC).

AstraZenecas supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) was based on results from a Phase III trial which showed Lynparza in combination with abiraterone reduced the risk of disease progression or death by 34% versus abiraterone alone. Median radiographic progression-free survival (rPFS) was 24.8 months for Lynparza plus abiraterone versus 16.6 for abiraterone alone.

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

The two companies formed a global strategic oncology collaboration in July 2017 to co-develop and co-commercialise Lynparza and MEK inhibitor Koselugo (selumetinib) for multiple cancer types.

Lynparza is currently approved in the US for patients with homologous recombination repair (HRR) gene-mutated mCRPC (BRCA-mutated 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 BRCA-mutated mCRPC who have progressed following prior therapy that included a new hormonal agent.