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U.S. FDA Approves Kite’s Tecartus® as the First and Only Car T for Adults With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia
-- 65% of Patients Achieved Overall Complete Remission with Tecartus -- -- High Unmet Need: Fifty Percent of Adult Patients Will Relapse on Currently
About this update from Gilead Sciences, Inc.
[{"type":"text","content":"\n-- 65% of Patients Achieved Overall Complete Remission with Tecartus --\n\n-- High Unmet Need: Fifty Percent of Adult Patients Will Relapse on Currently Available Treatments --\n\n-- Approval Marks Kite’s Fourth Indication for its Cell Therapies and First in Leukemia --\n\n SANTA MONICA, Calif.--(BUSINESS WIRE)--\nKite, a Gilead Company (Nasdaq: GILD), today announced the U.S. Food and Drug Administration (FDA) has granted approval for Tecartus® (brexucabtagene autoleucel) for the treatment of adult patients (18 years and older) with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Following FDA Breakthrough Therapy Designation and a priority review, Tecartus is the first and only chimeric antigen receptor (CAR) T-cell therapy approved for adults (18 years and older) with ALL. There is a high unmet need, as half of this patient population will relapse, and median overall survival (OS) is only approximately eight months with current standard-of-care treatments. Patients can access Tecartus through 109 authorized treatment centers across the U.S.\nThis press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211001005719/en/US Authorized Treatment Centers for CAR T-Cell Therapy (Graphic: Kite)\n“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, MD, ZUMA-3 investigator and medical oncologist, Moffitt Cancer Center, Tampa, 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.”\n\nThe approval is based on results from ZUMA-3, a global, multicenter, single-arm, open-label study in which 65% of the evaluable patients (n=54) achieved complete remission (CR) or CR with incomplete hematological recovery (CRi) at a median actual follow-up of 12.3 months. The duration of CR was estimated to exceed 12 months for more than half the patients. Among efficacy-evaluable patients, median duration of remission (DOR) was 13.6 months. Among the patients treated with Tecartus at the target dose (n=78), Grade 3 or higher cytokine release syndrome (CRS) and neurologic events occ...