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Kite: European CHMP Adopts Positive Opinion For KTE-X19

Kite, a unit of Gilead Sciences Inc. (GILD), said Friday that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency has issued a positive opinion on the company's Marketing Authorization Application for KTE-X19, a chimeric antigen receptor (CAR) T cell therapy.

The CHMP positive opinion is for KTE-X19 as a potential treatment for adult patients with relapsed or refractory mantle cell lymphoma following two or more lines of systemic therapy, including a Bruton's tyrosine kinase (BTK) inhibitor.

The CHMP opinion has recommended conditional marketing authorization, an early access pathway for medicines that show promising therapeutic effects, but for which comprehensive data are not available.

The European Commission will now review the CHMP recommendation and the final decision on the Marketing Authorization is expected in the coming months, Kite noted.

The CHMP recommendation was based on the positive benefit-risk for KTE-X19 from the safety and efficacy results of the ZUMA-2 trial.

Mantle cell lymphoma is a rare form of non-Hodgkin lymphoma that predominantly affects men above the age of 60.

Patients with relapsed or refractory mantle cell lymphoma after two or more lines of systemic therapy including a BTK have a poor prognosis, with a median overall survival of 6 to 10 months. In Europe, about 7,400 people are estimated to be diagnosed with mantle cell lymphoma each year.

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