FDA accepts new drug application from Epizyme in research drug tazemetostat

epithelial sarcoma is a very rare soft tissue malignancies that occur mainly in young people aged 20-40 years, with a total survival period of about 30 months (OS)Today, Epizyme announced thatFDA(http://accept its application fornew drug(http://(NDA) for theof theDrug(http:// and to grant it priority review eligibilityTazemetostat is an inhibitor of "first-in-class" histone lysine methyl transferase (Histone-Lysine N-methyltransferase) EZH2 for the treatment of metastatic/localized advanced epithelial sarcoma (epithelioid sarcoma) that is not suitable for surgical treatmentThe FDA will use the Accelerated Approval Channel to review the application, which is expected to be approved by January 23, 2020Epizyme's research and development strategy for tazemetostat includes three directions:one as a monotherapy for diseases that directly rely on EZH2 activity, including INI1-negative solid tumors, mesothelioma, non-Hodgkin's lymphoma (NHL), etc.
; The second is as a combination of chemotherapy treatment, combined with the chemotherapy drug R-CHOP, the treatment of diffuse large B-cell lymphoma (DLBCL), etc., and the thirdis combined with the immunocheckpoint inhibitor Tecentriq to treat non-small cell lung cancer (NSCLC) 　　The FDA's decision is based on positive results from tazemetostat's treatment of epithelial sarcoma cohort patients in the Phase 2 clinical (http:// 　　The results showed that the objective remission rate of tazemetostat was 15% and the disease control rate was 26% The median OS has not yet arrived 　　Safety aspects: tazemetostat also demonstrates good safety and tolerance