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European Commission Approves Gilead CAR T-cell Therapy Tecartus for Mantle Cell Lymphoma

NEW YORK – Gilead subsidiary Kite Pharma on Wednesday announced that the European Commission has granted conditional authorization for its CAR T-cell therapy brexucabtagene autoleucel (Tecartus) as a treatment for relapsed or refractory mantle cell lymphoma.

The EC's conditional marketing authorization, which could become permanent contingent on additional confirmatory data, specifies that patients eligible for the autologous therapy must have been previously treated with at least two lines of therapy, including a Bruton's tyrosine kinase inhibitor. Kite's treatment, which consists of autologous anti-CD19-transduced CD3-positive cells, received accelerated approval from the US Food and Drug Administration for the same mantle cell lymphoma indication in July.

The EC's decision to approve the treatment comes in the wake of positive results from the ongoing Phase II ZUMA-2 trial, in which 93 percent of 68 patients experienced tumor shrinkage after brexucabtagene autoleucel infusions and 67 percent achieved a complete response. The safety profile was manageable with 15 percent of patients experiencing grade 3 or higher cytokine release syndrome and 33 percent of patients experiencing grade 3 or higher neurologic events.