The US Food and Drug Administration (FDA) has finalized its guidance that outlines the eligibility and submission requirements for applicants interested in submitting new drug applications (NDAs) or biologics license applications (BLAs) for its real-time oncology review pilot (RTOR). In the final version, the agency rejected calls to expand the guidance to cover cell and gene therapies.
Overall, the guidance is little changed from the earlier draft issued in July 2022 (RELATED: FDA explains the ins and outs of real-time oncology review program in new guidance, Regulatory Focus 26 July 2022).
FDA said the final version clarifies some terminologies in the draft, clarifies the eligibility and submission process, and better aligns the guidance with the RTOR website.
The FDA Oncology Center of Excellence (OCE) announced the RTOR pilot in 2018 to facilitate earlier review of promising new treatments; the program enables sponsors to submit clinical trial data to FDA as it becomes available to support an earlier start to the application review…