Gilead: Kite's CAR T-cell Therapy Yescarta Gets EU Approval To Treat Relapsed Or Refractory FL

Gilead Sciences, Inc. (GILD) announced Tuesday that its cell therapy company Kite's CAR T-cell therapy Yescarta (axicabtagene ciloleucel) received European marketing authorization from the European Commission to treat relapsed or refractory follicular lymphoma or FL.

The approval is for the treatment of adult patients with relapsed or refractory FL after three or more lines of systemic therapy. Yescarta has maintained orphan medicinal product designation in this indication.

The approval is supported by data from the pivotal, single-arm Phase 2 ZUMA-5 international study in patients with relapsed or refractory FL who had received at least two prior lines of systemic therapy, including the combination of an anti-CD20 monoclonal antibody and an alkylating agent.

Follicular lymphoma is a form of non-Hodgkin lymphoma in which tumors grow slowly but can become more aggressive over time. FL is the second most common type of lymphoma globally and accounts for approximately 22% of all lymphomas diagnosed worldwide.

Christi Shaw, CEO, Kite, said, "This is the third approved indication for a Kite cell therapy in Europe, and we are pleased to enable more patients with different lymphomas greater access to this treatment innovation."

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