FDA Approval Insights: Obe-Cel in B-Cell Precursor ALL

Welcome to OncLive On Air^®! I’m your host today, Ashling Wahner.

OncLive On Air is a podcast from OncLive^®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

In today’s episode, we had the pleasure of speaking with Paul J. Shaughnessy, MD, about the FDA approval of obecabtagene autoleucel (obe-cel; Aucatzyl) for patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Dr Shaughnessy is the medical director of the Adult Blood and Marrow Stem Cell Transplant Program at Methodist Hospital in San Antonio, Texas.

On November 8, 2024, the FDA approved obe-cel for the treatment of adult patients with relapsed or refractory B-cell precursor ALL. This regulatory decision was supported by findings from the phase 1/2 FELIX trial (NCT04404660), in which 42% (95% CI, 29%-54%) of efficacy-evaluable patients with relapsed or refractory CD19-positive B-cell ALL who received the CAR T-cell product achieved a complete response (CR) within 3 months. The median duration of CR achieved within 3 months was 14.1 months (95% CI, 6.1-not reached).

In our exclusive interview, Dr Shaughnessy discussed the significance of this approval, key efficacy and safety findings from the pivotal FELIX trial, and where obe-cel currently fits into the ALL treatment paradigm.

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