Kite’s Yescarta (axicabtagene ciloleucel) Receives EC’s Approval for the Treatment of Relapsed or Refractory Follicular Lymphoma
- The EC has approved Yescarta for the treatment of adult patients with r/r FL after ≥3 lines of systemic therapy incl. the combination of an anti-CD20 mAb & alkylating agent
- The approval was based on the P-II (ZUMA-5) international study in 122 patients aged ≥18yrs. which showed ORR (91%) and CR rate (77%) at 24mos. analysis, m-DoR (38.6mos.), responders still in response (56%) @24mos.
- The safety profile was consistent with the known safety profile for Yescarta in all evaluable patients within ZUMA-5, grades ≥3 CRS were reported in 6% of patients, and neurologic events in 16% of patients, 99% of any grade resolved by the time of data cut-off and 60% of neurologic events were resolved within 3wks.
Ref: Businesswire | Image: Kite
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