By Michael Dabaie

 

Kite, part of Gilead Sciences Inc., said the European Medicines Agency Committee for Medicinal Products for Human Use issued a positive opinion on KTE-X19 for relapsed or refractory mantle cell lymphoma.

The CHMP opinion recommends conditional authorization, an early access pathway for medicines that show promising therapeutic effects, but for which comprehensive data aren't available.

The recommendation was based on the positive benefit-risk for KTE-X19 as demonstrated from the ZUMA-2 trial.

Mantle cell lymphoma is a rare form of non-Hodgkin lymphoma that arises from cells originating in the "mantle zone" of the lymph node and predominantly affects men over the age of 60.

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

 

Write to Michael Dabaie at michael.dabaie@wsj.com

 

(END) Dow Jones Newswires

October 16, 2020 08:18 ET (12:18 GMT)

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