FDA Panel Calls for Revamp in NSCLC Clinical Trials

The FDA’s Oncologic Drugs Advisory Committee (ODAC) has unanimously voted for a redesign of perioperative clinical trial protocols in resectable non-small cell lung cancer (NSCLC). The 11-0 decision addresses the need for assessing the contribution of each phase of treatment individually. This recommendation follows AstraZeneca's (AZ) application to approve Imfinzi for use before and after surgery in early-stage NSCLC. The phase 3 AEGEAN study showed that perioperative Imfinzi reduced the risk of recurrence, progression, or death by 32% compared to chemotherapy alone, but the trial design didn't allow for separate evaluation of each treatment phase.

The FDA previously advised AZ to demonstrate the effectiveness of each phase, but this was not incorporated into the trial design. Concerns were raised about the potential toxicities and lack of additional clinical benefit from overtreatment. Some ODAC panelists, including Dr. Pamela Kunz from Yale School of Medicine, emphasized the importance of providing clear evidence to help patients make informed decisions. The panel also discussed extending this requirement to other solid tumor trials, despite acknowledging that it could make clinical trials more complex and costly.

Although the committee did not vote on whether Imfinzi should be approved for the indication, many panelists supported its approval. Consumer representative David Mitchell argued against delaying access to the drug by requiring another study. While the FDA is not obligated to follow ODAC's recommendations, the committee's discussion highlighted the significant benefits of the Imfinzi-based regimen for resectable lung cancer patients. The FDA's decision is crucial, especially with similar approvals pending for other drugs like Bristol Myers Squibb’s Opdivo and Merck’s Keytruda, which share comparable trial designs.

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