Merck and AstraZeneca to face FDA AdCom meeting for prostate cancer therapy
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Merck (NYSE:MRK) and AstraZeneca (NASDAQ:AZN) announced Thursday that an expert panel of the FDA is set to discuss the companyâs request to expand the label for cancer therapy Lynparza as a combination regimen for certain patients with prostate cancer. 

A PARP inhibitor Lynparza is already indicated in the U.S. for multiple cancers including certain types of breast cancer, ovarian cancer and pancreatic cancer.
A supplemental new drug application (sNDA) for Lynparza is currently under the FDA review as a combination therapy with abiraterone and prednisone or prednisolone for adults with metastatic castration-resistant prostate cancer (mCRPC). 
Merck (MRK) and AstraZeneca (AZN) said that the FDAâs Oncologic Drugs Advisory Committee is set to meet on April 28, 2023 to discuss the label expansion.

The FDA's advisory committees issue non-binding recommendations. However, the regulator usually follows them before making a final decision on authorizations.
Last week, an EU panel recommended niraparib, a PARP inhibitor marketed by Johnson & Johnson (JNJ) and GSK (GSK) as a combination therapy for certain adults with mCRPC and BRCA1/2 mutations.