Lynparza combo accepted by FDA for priority review

UK pharma major AstraZeneca’s (LSE: AZN) supplemental New Drug Application (sNDA) for Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone has been accepted and granted Priority Review in the USA for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC).

Lynparza is being jointly developed and commercialized by AstraZeneca and US pharma giant Merck & Co (NYSE: MRK), which is known as MSD outside of the USA and Canada. The drug is already a blockbuster seller, with AstraZeneca taking in $2.7 billion and Merck booking $1 billion sales in 2021.

The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that offer significant advantages over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance. The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is anticipated during the fourth quarter of 2022.