The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted unanimously (11-0) in favor of approving tazemetostat tablets as a treatment for patients with metastatic or locally advanced epithelioid sarcoma that is ineligible for curative surgery.
The purpose of the hearing was to discuss data supporting a new drug application (NDA) for an accelerated approval of tazemetostat in this setting, and to determine whether the overall response rate (ORR) benefit with the EZH2 inhibitor was enough to warrant an indication and that it outweighed the risks of secondary malignancies.
The FDA granted a priority review designation to the NDA for tazemetostat in July 2019 for the treatment of patients with metastatic or locally advanced epithelioid sarcoma that is not eligible for curative surgery. The NDA is primarily based on findings from a cohort of patients with epithelioid sarcoma (cohort 5; n = 62) in an ongoing, single-arm, phase II study (Study EZH-202), which showed that the ORR was 15% (n = 9), comprised of 8 partial responses (PRs) and 1 complete response (CR).1
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