Pedal to the Metal: Assessing the FDA’s Real-Time Oncology Review Program

Posted by Matt Furlow on Apr 24, 2019 8:00:00 AM

Sharon Karlsberg and Manna Fujiu co-authored this post with Matt Furlow.

The FDA review process for oncology therapeutics is necessarily rigorous, but during that process cancer patients may be waiting to access new therapies—a matter of life or death in some cases. The FDA has been attempting to accelerate time to approval for oncology therapeutics for the past several years with accelerated approval, priority review, breakthrough designation and other programs and designations (table 1). Recently, the FDA’s Oncology Center of Excellence launched a pilot program for oncology therapeutics called Real-Time Oncology Review (RTOR). Under this program, manufacturers can submit analyses of their clinical data to the FDA as they become available but before a formal supplemental new drug application or supplemental biologics license application is submitted. After submission, the drug can potentially be approved in a matter of weeks or even days.

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