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# Allogene Therapeutics Gets FDA RMAT Designation
- URL: https://www.fdaweb.com/allogene-therapeutics-gets-fda-rmat-designation/
- Published: 2022-06-08T12:00:00.000Z
- Updated: 2026-09-14T17:47:45.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152014

FDA has granted Allogene Therapeutics a regenerative medicine advanced therapy designation for ALLO-501A in relapsed/refractory large B cell lymphoma. The designation was based on the potential of ALLO-501A to address the unmet need for patients who have failed other therapies, the company says. “Data support the potential of ALLO-501A to provide a safe and durable alternative to approved autologous CAR T therapies in CAR T naïve patients,” the company says. Allogene also says recent clinical data showed that ALLO-501A was associated with “consistent and manageable safety with no dose limiting toxicities or graft-vs-host disease” and minimal Grade 3 Immune Effector Cell-Associated Neurotoxicity Syndrome, or Grade 3 cytokine release syndrome adverse events.