Zonghai Li, MD, PhD
The FDA has granted a Regenerative Medicine Advanced Therapy (RMAT) designation to the investigational anti-BCMA CAR T-cell therapy CT053 for the treatment of patients with relapsed/refractory multiple myeloma.1
The company also stated that RMAT status comprises the same benefits of the FDA's Fast Track and Breakthrough Therapy designations, which provides intensive FDA guidance on efficient drug development, including the ability for early interactions with FDA senior management to discuss surrogate or intermediate endpoints, potential methods to support accelerated approval and satisfy postapproval requirements, potential priority review of the biologics license application, and other opportunities to expedite development and review.
- CARsgen Announces Investigational CAR-T Therapy CT053 Granted RMAT Designation by the U.S. FDA for R/R Multiple Myeloma. Carsgen Therapeutics. Published October 28, 2019. https://bit.ly/2PwNmtE. Accessed October 31, 2019.
- CARsgen Announces Investigational CAR-T Therapy CT053 Granted PRIME Eligibility by the European Medicines Agency. Carsgen Therapeutics. Published September 23, 2019. https://prn.to/321jNDo. Accessed October 31, 2019.
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