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Kite Receives CHMP Positive Opinion of Tecartus (brexucabtagene autoleucel) for Relapsed or Refractory Acute Lymphoblastic Leukemia

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Kite Receives CHMP Positive Opinion of Tecartus (brexucabtagene autoleucel) for Relapsed or Refractory Acute Lymphoblastic Leukemia

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  • The EMA's CHMP has issued a positive opinion for Tecartus (brexucabtagene autoleucel) to treat r/r B-cell precursor ALL in adult patients aged ≥26yrs. The EC’s decision on MAA is expected in the coming months
  • The P-I/II (ZUMA-3) results evaluate Tecartus in adult patients aged ≥18yrs. which showed that 71% of the evaluable patients achieved CR or CR with CRi at a median follow-up of 26.8mos. In an extended data for patients with a pivotal dose (n=78), the m-OS for all patients was 25.4mos. while 47mos. for responders 
  • In efficacy-evaluable patients, m-DoR was 18.6mos., patients treated with Tecartus at the target dose (n=100), ≥grade 3 or CRS & neurologic events were reported in (25% & 32%) of patients & were well-managed

Ref: Gilead | Image: Kite

Click here to­ read the full press release 

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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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