FX.co ★ AstraZeneca Reports ODAC's Review Of Imfinzi - Quick Facts

AstraZeneca (AZN.L, AZN) announced that the Food and Drug Administration's Oncologic Drugs Advisory Committee has recognized Imfinzi for meeting the primary endpoint of event-free survival in the treatment of resectable non-small cell lung cancer, based on results from the AEGEAN Phase III trial. The safety profile was deemed overall tolerable. The committee discussed that while the neoadjuvant and adjuvant components' contributions of the perioperative regimen couldn't be distinctly assigned due to the trial design, it remains a significant potential regimen for patients.

In September 2023, the FDA accepted the supplemental Biologics License Application (sBLA) for Imfinzi in this indication, following positive outcomes from the AEGEAN trial. The Oncologic Drugs Advisory Committee provides independent, expert advice and recommendations to the FDA regarding cancer treatments. The FDA will take this feedback into account during its review of the submission.