Epizyme’s Tazverik (tazemetostat) Receives the US FDA’s Accelerated Approval as the First Therapy for Epithelioid Sarcoma

Shots:

• The approval is based on clinical P-II clinical study assessing Tazverik (800mg, bid) in 62 patients aged ≥16yrs. with metastatic or LA epithelioid sarcoma not eligible for complete resection. The study measures how many patients experienced a complete or partial shrinkage of their tumors during the treatment
• The P-II clinical study results: tumor response assessments were performed every 8 wks. ORR (15%); CR (1.6%); PR (13%); DoR of 6mos. or longer (67%)
• Tazverik is the first and only FDA-approved EZH2 inhibitor with its expected launch in the US within 10 working days. Additionally, Epizyme will conduct post-marketing activities including clinical pharmacology evaluations assessing the effect of the therapy on liver function and the effect of CYP3A inhibitors and inducers on Tazverik

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