Update on US regulatory review of Lynparza in combination with abiraterone for metastatic castration-resistant prostate cancer
AstraZeneca and MSD announced that the 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 ODAC meeting is scheduled for 28 April 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), and subsequently published in the New England Journal of Medicine Evidence (previously cited). Further results from the final prespecified overall survival (OS) analysis were presented at ASCO GU 2023. Lynparza in combination with abiraterone and prednisone or prednisolone is approved in the EU and several other countries for the treatment of adult patients with mCRPC based on the PROpel trial.
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