Gilead's Mantle Cell Lymphoma Drug MAA Gets EMA Validation
Zacks Investment Research | Jan 28, 2020 10:06PM ET
Gilead Sciences Inc.’s (NASDAQ:GILD) company, Kite, announced that its Marketing Authorization Application (MAA) for KTE-X19 has been fully validated.Itis now under evaluation with the European Medicines Agency (EMA). KTE-X19 is an investigational chimeric antigen receptor (CAR) T cell therapy being developed for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). MCL is a rare form of non-Hodgkin lymphoma (NHL) that arises from cells originating in the "mantle zone" of the lymph node.
The MAA is supported by data from the single-arm, open-label, phase II ZUMA-2 study, which demonstrated an overall response rate of 93%, including 67% with complete response, as assessed by an Independent Radiologic Review Committee (IRRC) following a single infusion of KTE-X19 (median follow-up of 12.3 months).
Shares of the company have decreased 7.5% in the past year compared with the Zacks Investment Research
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