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# Allogene Myeloma Therapy Gains Regenerative Medicine Status
- URL: https://www.fdaweb.com/allogene-myeloma-therapy-gains-regenerative-medicine-status/
- Published: 2021-04-21T12:00:00.000Z
- Updated: 2026-09-14T16:55:49.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5149161

FDA has granted Allogene Therapeutics a Regenerative Medicine Advanced Therapy designation for ALLO-715 and its use in relapsed/refractory multiple myeloma. The designation was based on data demonstrating that the CAR T therapy ALLO-715 directed at B-cell maturation antigen can “achieve deep clinical responses while eliminating the need for bridging therapy and delays associated with autologous CAR T manufacturing,” the company says.

Initial results from the company’s UNIVERSAL study were presented at an oral session of the American Society of Hematology’s annual meeting in 12/2020, the company says. The study is also enrolling patients to receive ALLO-715 in combination with SpringWorks Therapeutics’ investigational gamma secretase inhibitor, nirogacestat.