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FDA Outlines New Accelerated Approval Strategy

December 2, 2022

December 2022

After recent criticism of the U.S. Food and Drug Administration’s (FDA) accelerated approval process for new oncology treatments, the FDA Oncology Center of Excellence has outlined a new strategy for granting and stripping the designation.

The current process has been scrutinized for several reasons, including the time it takes for confirmatory trials to be completed, the process for withdrawing indications, and the relationship between endpoints and clinical benefit.

On average, it took 3.1 years between accelerated approval and the completion of confirmatory trials and 3.8 years for an indication to be withdrawn.

As a result, the new strategy was designed to address these concerns. The doctors noted that under this strategy, sponsors should conduct adequate dose-optimization and activity-finding studies before seeking accelerated approval. Additionally, the FDA recommended that confirmatory trials be “well underway if not fully enrolled” by this time as well.

To address the lengthy process of indication withdrawal, the strategy recommends sponsors conduct a single randomized trial before accelerated approval or conduct two simultaneous trials, one single group and one randomized.

The plan also emphasized the importance of “procedures to build quality and efficiency into the [accelerated approval] on-ramp, which should include a prospective comprehensive strategy detailing plans for [accelerated approval] and the verification of clinical benefit, with the aim of expediting therapeutic advances and shortening this period of uncertainty.”

Source: The New England Journal of Medicine, September 21, 2022.

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