HUTCHMED Reports the NMPA’s NDA Acceptance of Tazemetostat for Treating Follicular Lymphoma
Shots:
- 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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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.