BRIEF—FDA to convene AdCom to review Lynparza sNDA

The US Food and Drug Administration (FDA) will convene a meeting of the Oncologic Drugs Advisory Committee (ODAC) to discuss the supplemental new drug application (sNDA) for Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC).

The drug is marketed by UK pharma major AstraZeneca in partnership with Merck & Co, which is known as MSD outside of the USA and Canada.

The ODAC meeting is scheduled for April 28, 2023.

AstraZeneca and MSD are committed to working with the FDA to bring Lynparza in combination with abiraterone to patients with mCRPC.

The efficacy and safety of Lynparza in combination with abiraterone and prednisone or prednisolone have been demonstrated in the PROpel Phase III trial, first presented at the 2022 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU).

Lynparza in combination with abiraterone and prednisone or prednisolone is approved in the European Union and several other countries for the treatment of adult patients with mCRPC based on the PROpel trial.