Gilead's Kite Says CHMP Adopts Positive Opinion for Lymphoma Drug
October 16 2020 - 8:33AM
Dow Jones News
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)
Copyright (c) 2020 Dow Jones & Company, Inc.
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