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FDA approves Kite’s Yescarta therapy for follicular lymphoma

pharmafile | March 9, 2021 | News story | Manufacturing and Production FDA, Kite, Yescarta 

The FDA has granted accelerated approval to Kite’s Yescarta treatment, a medicine for adult patients with relapsed or refractory follicular lymphoma (FL).

The approval, which follows FDA Breakthrough Therapy Designation and a priority review, makes Yescarta the first chimeric antigen receptor (CAR) T-cell therapy approved for patients with indolent FL.

The FDA’s decision follows initial results from the ZUMA-5 study, in which 146 patients, who had already received at least two prior lines of systemic therapy, were given a single dose of Yescarta. 

91% of patients with relapsed or refractory FL responded positively to Yescarta treatment, with an estimated 74% of patients still in remission at 18 months. 60% of patients in the study achieved a complete remission.

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

Dr Caron Jacobson, Medical Director of the Immune Effector Cell Therapy Program at the Dana-Farber Cancer Institute, said: “Once a follicular lymphoma patient’s disease relapses, the duration of response to care shortens with each round of therapy. 

“Additionally, for follicular patients in the third line of therapy, the five-year survival rate is only 20%, highlighting the urgent need for treatments that offer a real chance for durable remission.”

Christi Shaw, CEO of Kite, added: “As we look to bring the hope of survival to more patients in need, today’s FDA decision represents a real step forward in our commitment in haematologic malignancies.

“Advancing CAR T therapies for patients across lymphomas remains a cornerstone of our cell therapy development programme, and we are excited about the potential of Yescarta for patients with indolent follicular lymphoma.”

Jack Goddard

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