On January 23, 2020, the FDA granted accelerated approval to tazemetostat (Tazverik; Epizyme), a methyltransferase inhibitor, for the treatment of metastatic or locally advanced epithelioid sarcoma in adults and pediatric patients aged ≥16 years who are not eligible for complete resection.
“For people with epithelioid sarcoma, an aggressive life-threatening cancer that affects young adults, having new treatment options can offer much-needed hope,” said Denise Reinke, MS, NP, MBA, President and Chief Executive Officer, Sarcoma Alliance for Research Through Collaboration, and Co-Founder, Sarcoma Coalition, in a press release.
This approval was based on improvements in overall response rate (ORR) and duration of response (DOR) in a phase 2 clinical trial. Verification and description of clinical benefit in a confirmatory clinical trial(s) may be necessary for continued approval of tazemetostat for this indication.
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