Despite a complicated advisory committee review in July, AstraZeneca PLC obtained supplemental US Food and Drug Administration approval on 16 August for its PD-L1 inhibitor Imfinzi for perioperative treatment in resectable non-small cell lung cancer (NSCLC) meeting certain requirements, putting its drug on an equal footing in that setting with Merck & Co., Inc.'s Keytruda and ahead of Bristol Myers Squibb Company’s Opdivo.
Key Takeaways
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AstraZeneca received FDA approval for perioperative therapy with Imfinzi in early-stage resectable lung cancer, despite advisory panel reservations about clinical benefit
The indication clears Imfinzi (durvalumab) for use prior to surgery, in tandem with platinum-based chemotherapy, in early-stage NSCLC tumors no larger than 4cm or that are node-positive without epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements, as well as after surgery as monotherapy. Merck added a similar indication to the Keytruda (pembrolizumab) label in October 2023, while BMS’s Opdivo (nivolumab) is approved for neoadjuvant therapy in such patients, but not adjuvant treatment
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