The FDA likely will require an additional trial before approving AstraZeneca’s Imfinzi in resectable NSCLC for perioperative use due to the inability to distinguish whether the drug's efficacy is related to the neoadjuvant phase, the adjuvant phase, or both.
AstraZeneca’s situation is being used to highlight a broader FDA concern with trial designs for perioperative regimens and ODAC will vote on whether new agency requirements for NSCLC are needed.
Four-arm factorial designs are the optimal way to assess perioperative add-on treatment, the FDA says, but a three-arm design may be a practical alternative.

US FDA Sending AZ, Other Cancer Sponsors Trial Design Message With Imfinzi AdComm

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