AstraZeneca PLC’s Imfinzi became the second cancer immunotherapy approved for perioperative use in resectable non-small cell lung cancer (NSCLC) on 15 August, despite the US Food and Drug Administration’s prior suggestion that the first immunotherapy approved for this use, Merck & Co.’s Keytruda may have been a mistake.
AstraZeneca’s Imfinzi Squeezes Through: Is FDA Reversing Course Or In A Transition Period?
Even as US FDA expressed concern about the perioperative trial design, AstraZeneca’s ability to snag NSCLC indication without demonstrating the benefits of both the neoadjuvant and adjuvant phases of therapy highlights slow pace of agency policy shifts.
