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.
- It is unclear whether the FDA is backing away from a push for different trial designs in perioperative cancers or whether it is offering a transition period for applicants who were closer to approval when the agency changed its thinking
FDA raised concerns about the need for both neoadjuvant (pre-surgery) and adjuvant (post-surgery) treatment for this lung cancer indication as well as in oncology more broadly, ahead of and during
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