FDA approves Tecartus for B-cell precursor ALL
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The FDA approved brexucabtagene autoleucel for treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
Brexucabtagene autoleucel (Tecartus, Kite Pharma) is a CD19-directed genetically modified autologous T-cell immunotherapy, is the first chimeric antigen receptor T-cell therapy approved for this patient population.
Treatments for relapsed or refractory ALL include chemotherapy, targeted therapy or stem cell transplant. Approximately half of adults with relapsed or refractory B-cell precursor ALL relapse on available treatments, and median OS is about 8 months.
The FDA based the new indication on results of the phase 1/phase 2 ZUMA-3 study, which included adults with relapsed or refractory B-cell precursor ALL.
Patients underwent lymphodepleting chemotherapy and then received a single infusion of brexucabtagene autoleucel.
Twenty-eight evaluable patients (52%) achieved complete remission within 3 months. Median duration of complete remission was not reached; however, more than half of complete remissions lasted longer than 12 months.
“Adults with ALL face a significantly poorer prognosis compared [with] children,” Bijal Shah, MD, ZUMA-3 investigator and medical oncologist at Moffitt Cancer Center, said in a Kite-issued press release. “We now have a new meaningful advancement in treatment for these patients. A single infusion of Tecartus has demonstrated durable responses, suggesting the potential for long-term remission and a new approach to care.”
The FDA previously approved brexucabtagene autoleucel for treatment of adults with relapsed or refractory mantle cell lymphoma.
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