‘Me Too’ or Breakthrough? Exploring the Oncology Cell Therapy Pipeline

Posted by Katie Blodgett on Jun 26, 2019 8:00:00 AM

Last year, the American Society of Clinical Oncology (ASCO) designated adoptive cell immunotherapy the 2018 clinical cancer “advance of the year” following the 2017 FDA approvals of Kymriah (Novartis) and Yescarta (Kite, a Gilead company). In the year since, we have seen some incremental, notable approvals in the cell and gene therapy space, but we have yet to see additional cell therapy approvals in oncology. However, like a duck sailing smoothly across the water, the relative inactivity above the surface conceals a flurry of development activity taking place below the surface in the oncology pipeline.


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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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