Epizyme announces fast track designation for tazemetostat in DLBCL and provides solid tumour program update

Epizyme

28 November 2016 - FDA grants tazemetostat fast track designation for DLBCL with EZH2 activating mutations.

Epizyme today announced advancements in the company's clinical programs evaluating tazemetostat, its first-in-class EZH2 inhibitor. The U.S. FDA has granted tazemetostat fast track designation in patients with diffuse large B-cell lymphoma with EZH2 activating mutations. 

Additionally, Epizyme is focusing its Phase 2 registration-enabling study in adult patients with genetically-defined solid tumors on those cancers marked by loss of INI1, and has expanded enrolment in the epithelioid sarcoma cohort of the study based on encouraging early activity in this patient population.

Read Epizyme press release

Michael Wonder

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Michael Wonder

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Medicine , US , Submission , Fast track