FDA finalizes guidelines on real-time oncology review

The FDA published final guidelines for applicants submitting biologics license applications or new drug applications in its real-time oncology review pilot.

The final version states eligible submissions must demonstrate significant benefits over available treatment options; must not require an advisory committee meeting or new Risk Evaluation and Medication Strategy; and must include clinical trial end points that are "easily interpreted." 

The final version is not significantly different from the drafted guidelines posted July 22, 2022, according to a Nov. 7 report from Regulatory Focus. The final rule clarifies some terminologies, clarifies the eligibility and submission process, and aligns the guidance with the real-time oncology review website. It also rejected calls to expand the guidance to cover cell and gene therapies.

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