Kite Pharma Gains EU Conditional Authorization for Lymphoma Cell Therapy

Gilead Sciences subsidiary Kite Pharma has secured conditional marketing authorization in Europe for the first cell therapy for relapsed or refractory mantle-cell lymphoma.

The authorization for the company’s chimeric antigen receptor (CAR) T cell therapy, Tecartus, was supported by positive data from a phase 2 study in lymphoma patients who were previously given an anthracycline- or bendamustine-containing chemotherapy, an anti-CD20 antibody therapy and a Bruton Tyrosine Kinase enzyme inhibitor.

Participants showed an overall response rate of 93 percent, with 67 percent demonstrating a complete response, after receiving a single infusion of the therapy.