Kite’s Tecartus Receives EC’s Approval for the Treatment of Relapsed or Refractory Acute Lymphoblastic Leukemia
Shots:
- The approval was based on the P-I/II (ZUMA-3) study in adult patients aged 18yrs. with ALL whose disease is refractory or relapsed, following standard systemic therapy or HSCT
- The results showed that 71% of the evaluable patients achieved CR or CR with CRi with a median follow-up of 26.8mos., m-OS was 25.4mos. and 47mos. for responders (patients who achieved CR or CRi) & m-DoR was 18.6mos. in an efficacy-evaluable patients
- The safety results were consistent with the known safety profile for Tecartus while grade ≥3 CRS and neurologic adverse reactions were reported in 25% and 32% of patients, and the therapy was generally well managed. The therapy marks the first approved treatment option for patients
Ref: Gilead | Image: Gilead
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