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Imfinzi Adds Approval In Early-Stage Lung Cancer, Matching Keytruda

 
• By Joseph Haas

AstraZeneca is working to bolster its PD-L1 agent’s applicability in resectable non-small cell lung cancer, seeking advantages versus Merck’s Keytruda and Bristol’s Opdivo.

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AstraZeneca adds early-stage lung cancer perioperative indication to Imfinzi's label • Source: Shutterstock

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

  • 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...

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