The NMPA has accepted and granted priority review to the NDA of tazemetostat for treating adults with r/r follicular lymphoma
The NDA was based on P-II bridging trial evaluating safety and PK of tazemetostat for the treatment of r/r FL patients (n=42) with/without EZH2 mutations, with the 1EP as ORR and 2EPs as DoR, PFS & OS across China. Data will be highlighted at future conferences
Tazemetostat is a FIC EZH2 inhibitor which is developed by Epizyme (an Ipsen company) with HUTCHMED developing, manufacturing & commercializing it across China, Hong Kong, Macau & Taiwan as per an agreement b/w them. It has been approved in the US FDA under accelerated approval for r/r FL and advanced epithelioid sarcoma
Ref: Hutchmed | Image: Hutchmed
Related News:- HUTCHMED Reports the Initiation of Tazemetostat in Bridging Study for the Treatment of Follicular Lymphoma in China
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