USA – Industry groups: Expand FDA’s RTOR guidance to cell and gene therapies

Stakeholders commenting on the US Food and Drug Administration (FDA) draft guidance with recommendations for applicants submitting New Drug Applications (NDA) and Biologic License Applications (BLA) for Real-Time Oncology Review (RTOR) want more clarity on how the guidance applies to cell and gene therapies and have asked the agency to align the draft guidance with what appears on the RTOR website.

FDA’s draft guidance, released in July 2022, is intended to help industry identify oncology drugs that may qualify for RTOR, which would result in a head-start review by the agency and may decrease review time for sponsors. When RTOR was launched by the FDA Oncology Center of Excellence (OCE) in 2018, the program only included supplemental oncology drug applications, but now encompasses original oncology NDAs for new molecular entities and original oncology BLAs. (RELATED: FDA explains the ins and outs of real-time oncology review program in new guidanceRegulatory Focus 26 July 2022)…