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
Click here to read full press release/ article | Ref: Epizyme | Image: Epizyme
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