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New Indication Alert: FDA Approves AZ’s Imfinzi® (Durvalumab) Plus Chemo for NSCLC

Aug 16, 2024

On 16 August 2024, AstraZeneca announced that the FDA has approved its Imfinzi® (durvalumab), in combination with chemotherapy, for resectable early stage non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements.

This follows the FDA’s acknowledgement in July 2024 that Imfinzi® met the primary endpoint of event free survival in the treatment of resectable NSCLC, based on results of a Phase III study.  The FDA accepted the supplemental Biologics License Application (sBLA) for Imfinzi® in this indication in September 2023.