Autolus Therapeutics

Autolus receives FDA approval for AUCATZYL® (obe-cel) for treating adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL). The approval is based on the FELIX clinical trial results, showing a strong safety profile and efficacy, with 63% achieving overall complete remission. AUCATZYL will be manufactured at Autolus' commercial site in Stevenage, UK, and supplied globally.

Autolus Therapeutics' Aucatzyl, a CAR T-cell therapy targeting CD19, received FDA approval for treating adult B-cell precursor acute lymphoblastic leukemia (ALL). Aucatzyl differentiates itself with faster off-rate and lower complication rates, potentially improving safety and durability. The therapy's approval is based on a trial showing 42% complete remission within three months. Aucatzyl enters a market dominated by Amgen's Blincyto and Gilead's Tecartus, with potential for $300 million in peak sales.

The FDA approved obecabtagene autoleucel (obe-cel; Aucatzyl) for treating relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults. Obe-cel, a CD19-directed genetically modified autologous T-cell immunotherapy, does not require a Risk Evaluation and Mitigation Strategy (REMS) program. The approval was supported by the FELIX trial, which showed a 42% complete remission rate at 3 months and a median duration of CR of 14.1 months. The drug carries boxed warnings for cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, and secondary T-cell malignancies.

FDA approves Aucatzyl (obecabtagene autoleucel) for adult relapsed or refractory B-cell precursor ALL. Developed by Autolus, it's a CD19 CAR T-cell therapy with 63% overall complete remission in FELIX trial. No REMS required, but risks include CRS and neurologic toxicities.

FDA approves AUCATZYL, a CAR T therapy for adult r/r B-ALL, based on FELIX trial results. AUCATZYL showed 63% overall complete remission, low CRS, and no REMS requirement.

The U.S. FDA approves Autolus Therapeutics' Aucatzyl, a CD19-directed T cell immunotherapy, for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia, based on the FELIX study results.

Autolus Therapeutics received FDA approval for Aucatzyl, treating relapsed or refractory B-cell precursor ALL, with 42% achieving complete remission in a clinical study. The treatment marks Autolus' first commercial product, with EU and UK marketing authorization applications under review.

FDA approves obecabtagene autoleucel (obe-cel) for relapsed or refractory B-cell acute lymphoblastic leukemia (ALL), based on FELIX trial data showing 63% overall complete remission. Obe-cel, a CAR T-cell therapy, is the first FDA-approved treatment without a REMS program, with a boxed warning for CRS, neurologic toxicities, and secondary hematological malignancies.

FDA approves Aucatzyl (obecabtagene autoleucel) for adults with relapsed/refractory B-cell acute lymphoblastic leukemia, based on the FELIX clinical trial showing 63% overall complete remission and a median duration of remission of 14.1 months. Aucatzyl carries a boxed warning for cytokine release syndrome, neurologic toxicities, and secondary hematological malignancies.