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
