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FDA has granted regenerative medicine advanced therapy (RMAT) designation to Autolus’ CAR-T cell therapy obe-cel.
Autolus Therapeutics, a biopharmaceutical company focused on T cell therapies, announced on April 25, 2022 that FDA has granted regenerative medicine advanced therapy (RMAT) designation to its gene therapy obecabatagene autoleucel (obe-cel).
The therapy is a CD19-directed autologous chimeric antigen receptor (CAR)-T therapy meant for the treatment of adult relapsed/refractory B-Acute Lymphocytic Leukemia (B-ALL). FDA grants RMAT designation to drug candidates that may address significant unmet medical needs in patients with serious or life-threatening conditions. RMAT is designed to accelerate the drug development process by facilitating and expediting development and regulatory review. Obe-cel has been previously granted Priority Medicines (PRIME) designation by the European Medicines Agency (EMA) and Innovative Licensing and Access Pathway (ILAP) by the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom.
“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-ALL,” said Dr. Christian Itin, CEO of Autolus. “RMAT designation from FDA, PRIME designation from EMA and ILAP designation from MHRA facilitate regulatory interactions with key health authorities and supports our drive to bring this innovative therapy to patients as quickly as possible.”