FDA extends review of AstraZeneca/Merck's Lynparza's expanded use in prostate cancer
Iryna Drozd

The U.S. Food and Drug Administration (FDA) will extend the review period by three months of AstraZeneca (NASDAQ:AZN) and Merck's (NYSE:MRK) Lynparza to treat a type of prostate cancer to have more time to review the companies' application.
In August, the FDA accepted and granted priority review to the supplemental new drug application (sNDA) for 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 was expected to make a decision in Q4 2022.
The companies said on Thursday that they will continue to work with the FDA to facilitate the completion of the agency's review.
The sNDA was backed by data from a phase 3 trial called PROpel.
In November, a panel of the European Medicines Agency (EMA) had recommended the expanded approval of Lynparza for similar use in the EU.
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; and in the in the EU, Japan, and China for patients with BRCA-mutated mCRPC who have progressed following prior therapy that included a new hormonal agent.