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Epizyme’s TAZVERIK Granted Accelerated Approval

Becomes first and only EZH2 inhibitor approved by the FDA

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By: Kristin Brooks

Managing Editor, Contract Pharma

Epizyme, Inc. was granted accelerated approval of TAZVERIK (tazemetostat) from the U.S. FDA for the treatment of metastatic or locally advanced epithelioid sarcoma not eligible for complete resection, based on overall response rate and duration of response in a Phase II trial. The efficacy of TAZVERIK was evaluated in an open-label, single-arm cohort in patients with histologically confirmed, metastatic or locally advanced epithelioid sarcoma. Patients received TAZVERIK 800 mg orally twice d...

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