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FDA Halts Enrollment on Tazemetostat Trials

Jason M. Broderick @jasoncology
Published: Monday, Apr 23, 2018

Robert Bazemore
Robert Bazemore
The FDA has halted enrollment on clinical trials of tazemetostat in patients with various solid tumors and hematologic malignancies, according to Epizyme, the manufacturer of the EZH2 inhibitor.

The FDA in April 2017 granted fast track status to tazemetostat for the treatment of patients with relapsed or refractory follicular lymphoma, either wild type EZH2 or with EZH2 activating mutations. The agency granted the drug Fast Track status in 2016 for patients with relapsed/refractory diffuse large B-cell lymphoma with EZH2-activating mutations.
Gounder MM, Stacchiotti S, Schöffski P, et al. Phase 2 multicenter study of the EZH2 inhibitor tazemetostat in adults with INI1 negative epithelioid sarcoma (NCT02601950). J Clin Oncol. 35, 2017 (suppl; abstr 11058).

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