AstraZeneca’s Imfinzi Gets Pass From FDA Advisors But Future Perioperative Drugs Don’t

The Oncologic Drugs Advisory Committee urged the FDA not to delay Imfiniz’s perioperative NSCLC indication, while also unanimously pushing for better trial designs in lung cancer and all resectable tumors.

black and white image of doctor with floating lungs above doctor's hands. — The ODAC discussion may have saved AstraZeneca's Imfinizi from a complete response letter. • Source: Shutterstock

A US Food and Drug Administration advisory committee appeared supportive of granting AstraZeneca PLC’s Imfinzi (durvalumab) a supplemental indication for perioperative use in resectable non-small cell lung cancer (NSCLC), despite the agency’s frustration that the sponsor did not demonstrate the full duration of therapy, particularly the post-surgery treatment, is necessary.

Key Takeaways

ODAC does not want the FDA to delay AstraZeneca’s Imfinizi approval for perioperative use in NSCLC despite uncertainty about whether patients need the full treatment duration.
The committee still voted unanimously that future perioperative applications should have determine the contribution of each treatment phase

However, while AstraZeneca warranted a pass, the Oncologic Drugs Advisory Committee agreed with the FDA that better trial designs should be required for future

AstraZeneca’s Imfinzi Gets Pass From FDA Advisors But Future Perioperative Drugs Don’t

Key Takeaways

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