New FDA approval for AstraZeneca's Lynparza

Following a mixed advisory panel vote in late April, the US Food and Drug Administration FDA) said yesterday that it has approved UK pharma major AstraZeneca’s (LSE: AZN) Lynparza (olaparib).

Lynparza is cleared for use in combination with with abiraterone (Johnson & Johnson's Zytiga) and prednisone (or prednisolone) for adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC), as determined by an FDA-approved companion diagnostic test.

Already among the UK drugmaker’s top-selling drugs with first-quarter 2023 sales of $701 million, Lynparza, which is being jointly developed and commercialized by AstraZeneca and US pharma giant Merck & Co (NSE: MRK), known as MSD outside of the USA and Canada, has been used to treat over 75,000 patients worldwide. Following this approval for Lynparza in the USA, AstraZeneca will receive a regulatory milestone payment from MSD, anticipated to be booked as Collaboration Revenue by the company and confirmed in the second quarter 2023 results.