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Kite’s Tecartus® Approved by FDA as First CAR-T for Adults with Relapsed or Refractory B-cell Acute Lymphoblastic Leukaemia

Georgi Makin
6 October 2021
Through the FDA Breakthrough Therapy Designation as well as priority review, this approval makes Tecartus the first and only CAR-T for adults, the first therapeutic for leukaemia from Kite, and the fourth indication for Kite’s cell therapies portfolio.

Kite has announced that the FDA has granted approval for the use of Tecartus (brexucabtagene autoleucel) in adults aged 18 years or over for the treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukaemia.

A press release from Kite explains how this approval serves a high unmet need as approximately half of the designated patient population are likely to experience relapse following traditional treatment options, with a median overall survival of approximately 8 months.

The approval follows results from ZUMA-3, a global, multicentre clinical trial that sort to determine the percentage of participants that experienced dose-limiting toxicities, as well as overall complete remission rate.

“Adults with acute lymphoblastic leukaemia face a significantly poorer prognosis compared to children, and roughly half of all adults with B-ALL will relapse on currently available therapies,” explained Bijal Shah, ZUMA-3 Investigator and Medical Oncologist at the Moffitt Cancer Centre in Florida.

“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,” Bijal Shah continued.

Results from the trial indicated that 65% of the 54 evaluable patients achieved complete remission or complete remission with incomplete haematological recovery at a median actual follow-up of 12.3 months, with the duration of complete remission estimated to exceed 12 months for more than 50% of patients.

Christi Shaw, CEO of Kite commented:

“Today marks Kite’s fourth FDA approved indication in cell therapy in under 4 years, demonstrating our commitment to advancing CAR-T for patients across many different hematologic malignancies. 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 acute lymphoblastic leukaemia.”

“Roughly half of all acute lymphoblastic leukaemia cases actually occur in adults, and unlike paediatric acute lymphoblastic leukaemia, adult acute lymphoblastic leukaemia has historically had a poor prognosis,” explaied Lee Greenberger, CSO of The Leukaemia & Lymphoma Society.

One of the key benefits of a CAR-T therapy like Tecartus is that patients may be able to avoid unsuccessful rounds of multiple therapeutic options, such as chemotherapy and targeted therapies.

“Developing new therapies that would be life-changing for people with cancer has been a dream of The Leukaemia & Lymphoma Society. We are proud to see the potential of CAR-T realized for even more people with this approval for brexucabtagene autoleucel,” Lee Greenberger concluded.

Patients can access Tecartus through 109 authorised treatment centres across the US. Tecartus is also currently under review for the same conditions in the UK and Europe.

Source: Kite press release