Gilead's CAR-T cell therapy Tecartus gains FDA approval for B-cell acute lymphoblastic leukaemia

Gilead Sciences' Kite unit announced Friday that the FDA granted approval to its filing for Tecartus (brexucabtagene autoleucel) for the treatment of adults, aged 18 and older, with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL), which the company said represents the first and only CAR T-cell therapy authorised for adults with ALL.  

CEO Christi Shaw remarked that "Tecartus has already transformed outcomes for adults living with mantle cell lymphoma, and we look forward to offering the hope for a cure to patients with ALL." 

The FDA approval is based on results from the Phase I/II ZUMA-3 study, which enrolled adults with relapsed or refractory B-cell precursor ALL. Patients received a single infusion of Tecartus following completion of lymphodepleting chemotherapy. The efficacy outcome measures used to support the approval were complete response (CR) achieved within three months from infusion and duration of CR.

Complete response exceeding 12 months

Results showed that of the 54 patients evaluable for efficacy, 28 achieved CR within three months. With a median follow-up for responders of 7.1 months, the median duration of CR was not reached; the duration of CR was estimated to exceed 12 months for more than half the patients.

"Adults with ALL face a significantly poorer prognosis compared to children, and roughly half of all adults with B-ALL will relapse on currently available therapies," said Bijal Shah, ZUMA-3 investigator. Shah added "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."

Tecartus is under review in Euope and UK for the treatment of adults with relapsed or refractory B-cell precursor ALL.

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