Real-time reviews for cell and gene therapies? Pfizer to FDA: Yes, please

The FDA’s Oncology Center of Excellence has a program, known as Real-Time Oncology Review (RTOR), that speeds up cancer drug approvals, sometimes by months, but has always been restricted to cancer drugs — first with supplements and then moving on to full approvals.

How RTOR works: earlier submissions of topline efficacy and safety results from sponsors, prior to the submission of the complete application, help to support an earlier start to the FDA’s evaluation of the complete application.

In draft guidance from this summer on RTOR, however, the agency quietly (via a footnote) mentioned that:

RTOR may not be suitable for certain biological products, such as cell and gene therapies, for which complex manufacturing and product characteristics need to be considered in evaluating the safety and efficacy of the product. For these types of products, we recommend that a discussion of whether the product is suitable…
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