Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we have a quick update on another recent FDA cancer therapeutic approval.
On October 1, 2021, the FDA approved brexucabtagene autoleucel (brand name Tecartus) for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
Efficacy was evaluated in ZUMA-3, a single-arm multicenter trial that evaluated brexucabtagene autoleucel, a CD19-directed chimeric antigen receptor T-cell therapy, in adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. Patients received a single infusion of brexucabtagene autoleucel following completion of lymphodepleting chemotherapy.
The efficacy outcome measures used to support approval were complete response achieved within 3 months from infusion and duration of complete response. Of the 54 patients evaluated for efficacy, 28 achieved complete response within 3 months. With a median follow-up for responders of 7.1 months, the median duration of complete response was not reached; the duration of complete response was estimated to exceed 12 months for more than half the patients.
The prescribing information for brexucabtagene autoleucel has a boxed warning for cytokine release syndrome and neurologic toxicities. Cytokine release syndrome occurred in 92% of patients and neurologic toxicities occurred in 87%.
This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.
Full prescribing information for these approvals can be found on the web at www.fda.gov/, key word search Approved Cellular and Gene Therapy Products. Health care professionals should report serious adverse events to FDA’s MedWatch Reporting Program at www.fda.gov/medwatch.