AstraZeneca’s Imfinzi Squeezes Through: Is FDA Reversing Course Or In A Transition Period?

 
• By Sarah Karlin-Smith
  
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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.

series of doors starting with each door being more open than the last
Imfinzi's perioperative NSCLC indication got through FDA on a data set that may soon shut other sponsors out. • Source: Shutterstock

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.

Key Takeaways

  • Agency approves second checkpoint inhibitor for perioperative use in resectable NSCLC without data on the contribution of each phase of therapy, despite prior statements that suggested it was a mistake to not have this data premarket.

FDA raised concerns about the need for both neoadjuvant (pre-surgery) and adjuvant (post-surgery) treatment for this lung cancer indication as...

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