FDA Grants Approval to Obecabtagene Autoleucel for R/R B-Cell Precursor Acute Lymphoblastic Leukemia

On November 8, 2024, the US Food and Drug Administration approved CD19-directed genetically modified autologous T cell immunotherapy obecabtagene autoleucel for the treatment of patients with relapsed/refractory (R/R) B-cell precursor acute lymphoblastic leukemia (ALL).

This approval was based on results from the FELIX trial, an open-label, multicenter, single-arm trial that enrolled adults with R/R CD19-positive B-cell ALL, who either: relapsed following a remission lasting 12 months or less, had relapsed/refractory ALL following 2 or more prior lines of systemic therapy, or had disease that was relapsed/ refractory 3 or more months after allogeneic stem cell transplantation. 

The trial’s central efficacy outcomes were rate and duration of complete remission (CR) achieved within 3 months after infusion. Secondary measures were rate and duration of overall complete remission which includes complete remission and complete remission with incomplete hematologic recovery (CRi), at any time. The study found that 27 patients (42%; 95% confidence interval [CI], 29% to 54%) out of the 65 who were evaluable for efficacy achieved CR within 3 months. The median duration of CR achieved within 3 months was 14.1 months (95% CI, 6.1 to not reached). 

The prescribing information has a boxed warning for cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS) and T cell malignancies. CRS occurred in 75% (Grade 3, 3%) and neurologic toxicities occurred in 64% (Grade ≥ 3, 12%), including ICANS in 24% (Grade ≥ 3, 7%).The most common non-laboratory adverse reactions (incidence ≥ 20%) 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.

Source:

FDA approves obecabtagene autoleucel for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. US Food and Drug Administration. Accessed November 8, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-obecabtagene-autoleucel-adults-relapsed-or-refractory-b-cell-precursor-acute