AstraZeneca/Merck's Lynparza gets FDA priority review to treat prostate cancer subtype
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The U.S. Food and Drug Administration (FDA) granted priority review to AstraZeneca (NASDAQ:AZN) and Merck's (NYSE:MRK) Lynparza in combination with Johnson & Johnson's (NYSE:JNJ) Zytiga (abiraterone), and prednisone or prednisolone to treat adult patients with metastatic castration-resistant prostate cancer (mCRPC).

The FDA accepted the company's supplemental new drug application (sNDA) and is expected to make a decision in Q4 2022. Under priority review, the FDA's goal is to take action within six months, compared to 10 months under standard review.
The sNDA was backed by data from a phase 3 trial called PROpel, the British pharma giant said in an Aug. 16 press release.
Lynparza (olaparib) is already approved in the U.S. to treat patients with HRR gene-mutated mCRPC (BRCA-mutated and other HRR gene mutations) who have progressed following prior treatment with Zytiga (abiraterone) or enzalutamide, sold as Xtandi by Pfizer and Astellas.