AstraZeneca, Merck's Lynparza gets approval in EU for expanded use in prostate cancer
artJazz


The European Commission (EC) approved AstraZeneca (NASDAQ:AZN) and Merck's (NYSE:MRK) Lynparza in combination with abiraterone and prednisone or prednisolone, to treat adult men with metastatic castration-resistant prostate cancer for whom chemotherapy is not clinically indicated.
The EC approval of Lynparza (olaparib) was backed by data from a phase 3 trial called PROpel. The decision follows a recommendation for approval by a panel of the European Medicines Agency (EMA) in November.

"Lynparza in combination with abiraterone has been shown to reduce the risk of disease progression by 34% versus the standard of care treatment in the PROpel trial," said Dave Fredrickson, executive vice president, Oncology Business Unit, AstraZeneca.
Lynparza is already approved to treat certain patients with types of breast, ovarian, pancreatic, and prostate cancers in the EU.
Following this approval for Lynparza in the EU, AstraZeneca will receive a regulatory milestone payment of $105M from Merck, which is expected to be booked as collaboration revenue by the British drugmaker during Q4 2022.
The drug combo is under priority in the U.S. for similar use and the FDA is expected to make a decision on during Q1 2023.