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Investigational CD19-Directed CAR-T Therapy Granted FDA’s RMAT Designation

FDA

The U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to obecabatagene autoleucel (obe-cel), a CD19-directed autologous chimeric antigen receptor (CAR) T-cell therapy.

Obe-cel is being investigated for adults with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL) in the ongoing, phase II FELIX study.

The RMAT designation is given to drug candidates in recognition of the therapy’s potential to address significant unmet medical needs in patients with serious or life-threatening conditions.

“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 Christian Itin, Chief Executive Officer of Autolus. “RMAT designation from FDA, PRIME designation from [the European Medicines Agency], and [Innovative Licensing and Access Pathway] designation from [the Medicines and Healthcare products Regulatory Agency] facilitate regulatory interactions with key health authorities and supports our drive to bring this innovative therapy to patients as quickly as possible.”

According to a press release, compared with current CD19 CAR T-cell therapies, obe-cel is “designed to have a fast target binding off-rate to minimize excessive activation of the programmed T cells.” The therapy “may reduce toxicity and be less prone to T-cell exhaustion, which could enhance persistence and improve the ability of the programmed T cells to engage in serial killing of target cancer cells.”

FELIX is currently enrolling adult patients with relapsed/refractory B-precursor ALL.

Source: Autolus Press Release, April 2022

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