On April 21, 2021 Allogene Therapeutics, Inc., a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) therapies for cancer, reported that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to ALLO-715 in relapsed/refractory multiple myeloma (Press release, Allogene, APR 21, 2021, View Source [SID1234631116]). The FDA granted RMAT designation based on the potential of ALLO-715 to address the growing unmet need for patients who have failed other multiple myeloma therapies.
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"RMAT designation was granted based on our encouraging initial clinical experience in heavily pretreated patients. ALLO-715 demonstrated for the first time that an allogeneic CAR T therapy directed at BCMA can achieve deep clinical responses while eliminating the need for bridging therapy and delays associated with autologous CAR T manufacturing," said Rafael Amado, M.D., Executive Vice President of Research and Development and Chief Medical Officer. "We look forward to completing the UNIVERSAL study and working closely with the FDA as we seek to rapidly advance this important therapeutic alternative to patients with advanced multiple myeloma."
Initial results from the UNIVERSAL study were presented at an oral session of the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December 2020. As part of the Company’s anti-BCMA strategy, the Phase 1 UNIVERSAL study continues to optimize the dosing regimen of ALLO-715 and ALLO-647. The UNIVERSAL study is also enrolling patients to receive ALLO-715 in combination with SpringWorks Therapeutics’ investigational gamma secretase inhibitor, nirogacestat.
Established under the 21st Century Cures Act, RMAT designation is a dedicated program designed to expedite the development and review processes for promising pipeline products, including cell therapies, that includes all the benefits of Fast Track and Breakthrough designation. An investigational cell therapy is eligible for RMAT designation if it is intended to treat, modify, reverse, or cure a serious or life-threatening disease; and preliminary clinical evidence indicates that the therapy has the potential to address unmet medical needs for that disease. Advantages of the RMAT designation include early interactions with FDA that may be used to discuss potential surrogate or intermediate endpoints and potential ways to satisfy post approval requirements.