FDA grants RMAT designation to obecabatagene autoleucel for acute lymphoblastic leukemia
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The FDA granted regenerative medicine advanced therapy designation to obecabatagene autoleucel for the treatment of adults with relapsed or refractory B-cell acute lymphoblastic leukemia.
Obecabatagene autoleucel (AUTO1; Autolus Therapeutics) — also referred to as obe-cel — is an autologous, gene-edited chimeric antigen receptor T-cell therapy that targets the CD19 protein on the surface of cancer cells.
The investigational agent is designed to have “a fast target-binding off-rate” with the aim of reducing treatment-related toxicity and T-cell exhaustion to enhance the persistence and efficacy of the treatment, according to the manufacturer.
The phase 2 FELIX trial will evaluate the efficacy and safety of obe-cel for adults with relapsed or refractory B-cell ALL. Researchers intend to enroll up to 140 patients across the U.S. and Europe in the international multicenter study.
“RMAT designation is an important regulatory milestone for obe-cel and highlights its potential to address the unmet medical need for adult patients with relapsed and refractory B-[cell] ALL,” Christian Itin, PhD, CEO of Autolus, said in a company-issued press release. “RMAT designation from FDA ... facilitate[s] regulatory interactions with key health authorities and supports our drive to bring this innovative therapy to patients as quickly as possible.”
The FDA’s RMAT designation program — part of the 21st Century Cures Act — is designed to expedite review of regenerative medicine therapies intended to treat, modify, reverse or cure serious or life-threatening diseases or conditions. Preliminary clinical evidence must indicate the therapy has the potential to address unmet medical needs.
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