FDA News

FDA grants priority review to tazemetostat for epithelioid sarcoma

The FDA granted priority review to tazemetostat for the treatment of patients with metastatic or locally advanced epithelioid sarcoma who are not eligible for curative surgery.

Tazemetostat (Epizyme) is an oral EZH2 inhibitor that is being evaluated as monotherapy for patients with certain molecularly defined solid tumors, as well as for patients with follicular lymphoma. Other studies are evaluating tazemetostat as part of combination treatment for patients with diffuse large B-cell lymphoma.

“We are thrilled with FDA’s acceptance of this first tazemetostat new drug application submission for priority review, and to be an important step closer to achieving our mission of rewriting treatment for patients with cancer and other serious diseases,” Robert Bazemore, president and CEO of Epizyme, said in a company-issued press release. “If approved, we believe tazemetostat could become an important new option in the treating physicians’ arsenal.”

Epizyme is seeking accelerated approval of tazemetostat for epithelioid sarcoma. The FDA is expected to make a decision on tazemetostat for this indication by Jan. 23.

The priority review designation is based primarily on data from a phase 2 study that included 62 patients with epithelioid sarcoma. Results — presented at this year’s ASCO Annual Meeting — showed tazemetostat resulted in durable responses and generally was well-tolerated.

Epizyme intends to initiate a global confirmatory trial to support full approval for this indication. Approximately 150 patients will be randomly assigned 1:1 to front-line treatment with doxorubicin plus either tazemetostat or placebo. PFS will be the primary endpoint. Secondary endpoints will include OS, disease control rate, overall response rate and duration of response.

The FDA granted priority review to tazemetostat for the treatment of patients with metastatic or locally advanced epithelioid sarcoma who are not eligible for curative surgery.

Tazemetostat (Epizyme) is an oral EZH2 inhibitor that is being evaluated as monotherapy for patients with certain molecularly defined solid tumors, as well as for patients with follicular lymphoma. Other studies are evaluating tazemetostat as part of combination treatment for patients with diffuse large B-cell lymphoma.

“We are thrilled with FDA’s acceptance of this first tazemetostat new drug application submission for priority review, and to be an important step closer to achieving our mission of rewriting treatment for patients with cancer and other serious diseases,” Robert Bazemore, president and CEO of Epizyme, said in a company-issued press release. “If approved, we believe tazemetostat could become an important new option in the treating physicians’ arsenal.”

Epizyme is seeking accelerated approval of tazemetostat for epithelioid sarcoma. The FDA is expected to make a decision on tazemetostat for this indication by Jan. 23.

The priority review designation is based primarily on data from a phase 2 study that included 62 patients with epithelioid sarcoma. Results — presented at this year’s ASCO Annual Meeting — showed tazemetostat resulted in durable responses and generally was well-tolerated.

Epizyme intends to initiate a global confirmatory trial to support full approval for this indication. Approximately 150 patients will be randomly assigned 1:1 to front-line treatment with doxorubicin plus either tazemetostat or placebo. PFS will be the primary endpoint. Secondary endpoints will include OS, disease control rate, overall response rate and duration of response.