FDA Approval Insights: Obe-Cel in B-Cell Precursor ALL
Season 11, Episode 38, Nov 28, 07:00 PM
Dr Shaughnessy discusses the significance of the FDA approval of obe-cel for patients with relapsed or refractory B-cell precursor ALL.
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.
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.