On 25 July 2024, AstraZeneca announced the FDA’s Oncologic Drugs Advisory Committee acknowledged that its Imfinzi® (durvalumab) met the primary endpoint of event-free survival (EFS) in the treatment of resectable non-small cell lung cancer (NSCLC), based on Phase III results. The FDA accepted the supplemental Biologics License Application (sBLA) for Imfinzi® in this indication in September 2023.
Earlier this month, AstraZeneca announced that its Imfinzi® and Lynparza® (olaparib) combination had been recommended for approval by the EMA’s Committee for Medicinal Products for Human Use (CHMP) for certain patients with primary advanced or recurrent endometrial cancer.