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# FDA Orphan Drug Designation for Allogene Cancer Drug
- URL: https://www.fdaweb.com/fda-orphan-drug-designation-for-allogene-cancer-drug/
- Published: 2021-08-12T12:00:00.000Z
- Updated: 2026-09-14T17:10:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149927

FDA has granted orphan drug designation to Allogene Therapeutics’ ALLO-715 to treat multiple myeloma. A company [statement](https://www.marketwatch.com/press-release/allogene-therapeutics-receives-fda-orphan-drug-designation-odd-for-allo-715-for-the-treatment-of-multiple-myeloma-mm-2021-08-12-81843043?tesla=y&ref=fdaweb.com) says initial results from the Phase 1 UNIVERSAL study of ALLO-715 in relapsed/refractory multiple myeloma demonstrated that an allogeneic CAR T therapy directed at B-cell maturation antigen can achieve clinical responses while eliminating the need for bridging therapy or delays in treatment associated with manufacturing. The agency previously granted ALLO-715 a regenerative medicine advanced therapy designation.