The FDA announced that it has approved AstraZeneca’s Lynparza® (olaparib) with abiraterone and prednisone (or prednisolone) for patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer, as determined by an FDA-approved companion diagnostic test. Following this approval, AstraZeneca announced that it will receive a regulatory milestone payment from MSD, anticipated to be confirmed in Q2 2023 results.
This news follows the FDA’s Oncologic Drugs Advisory Committee vote to support FDA approval of Lynparza® with abiraterone and prednisone (or prednisolone) for the above indication in April 2023.