AstraZeneca Reports ODAC's Review Of Imfinzi - Quick Facts

(RTTNews) - AstraZeneca (AZN.L, AZN) said the Food and Drug Administration's Oncologic Drugs Advisory Committee acknowledged that Imfinzi met the primary endpoint of event-free survival in the treatment of resectable non-small cell lung cancer based on the AEGEAN Phase III trial results with an overall tolerable safety profile. The discussion noted that while the contribution by phase of neoadjuvant and adjuvant components of the perioperative regimen could not be clearly assigned based on the trial design, this is an important potential regimen for patients.

The FDA accepted the sBLA in September 2023 for Imfinzi in this indication based on positive results from the pivotal AEGEAN trial. The ODAC provides the FDA with independent, expert advice and recommendations on medicines for use in the treatment of cancer. The FDA will consider the feedback as it reviews the submission.

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