Kite Reports Submission of sBLA to the US FDA for Tecartus in Adult Patients with R/R Acute Lymphoblastic Leukemia

April 2, 2021 Auto Bot Adult, FDA, Kite, patients, regulatory, reports, sBLA, Submission, Tecartus 0

Shots:

  • The sBLA is based on data from the P- I/II ZUMA-3 trial in adult patients age ≥18 years old for the treatment of adult patients with r/r B-cell ALL
  • The focus of the study is to evaluate the safety and efficacy in adult patients with r/r ALL
  • If approved, Tecartus will be the 1st and only CAR T-cell therapy approved for adult patients. In July 2020, Tecartus received an accelerated approval from the US FDA for the treatment of r/r mantle cell lymphoma, based on ORR and DOR

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