The CD19-directed genetically modified autologous T-cell immunotherapy, obecabtagene autoleucel (Aucatazyl; Autolus Inc.), has been approved for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).1
Officials with the FDA based their approval on results from the FELIX (NCT04404660) clinical trial, an open-label, multicenter, single-arm trial that enrolled adults with relapsed or refractory CD19-positive B-cell ALL, who had relapsed following a remission lasting 12 months or less, relapsed or refractory ALL following 2 or more prior lines of systemic therapy, or disease that was relapsed or refractory 3 or more months after allogeneic stem cell transplantation.
Of the 65 patients evaluable for efficacy, 27 patients (42%; 95% confidence interval [CI], 29%-54%) achieved complete remission within 3 months. The median duration of CR achieved within 3 months was 14.1 months (95% CI: 6.1, not reached).
FDA officials noted in a statement that the prescribing information carries a boxed warning for cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS) and T-cell malignancies.
The most common non-laboratory adverse reactions (incidence ≥20%) according to the FDA statement, “included CRS, infections-pathogen unspecified, musculoskeletal pain, viral infections, fever, nausea, bacterial infectious disorders, diarrhea, febrile neutropenia, ICANS, hypotension, pain, fatigue, headache, encephalopathy, and hemorrhage.”
The approval was announced on November 8, 2024.
References
- FDA. FDA approves obecabtagene autoleucel for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. Published November 8, 2024. Accessed November 19, 2024. https://www.fda.gov/drugs/resources- information-approved-drugs/fda-approves-obecabtagene-autoleucel-adults-relapsed-or-refractory-b-cell-precursor-acute