Epizyme (NASDAQ:EPZM) submitted an NDA to the FDA for tazemetostat for the treatment of metastatic or locally advanced epithelioid sarcoma.
Epithelioid sarcoma is a very rare soft tissue sarcoma. Tazemetostat is a small molecule EZH2 inhibitor that inhibits proliferation of epithelioid sarcoma cells.
“Our epithelioid sarcoma program is strategically valuable to Epizyme and helps streamline our planned NDA submission in the fourth quarter for patients with follicular lymphoma,” Robert Bazemore, Epizyme’s president and CEO, said in a statement.
The NDA submission is based on updated data from and ongoing Phase 2 clinical trial of 62 epithelioid sarcoma patients.
Epizyme is investigating tazemetostat, as a monotherapy and in combination with chemotherapy or immunotherapy, in multiple clinical trials. Indications include non-Hodgkin lymphoma, mesothelioma, synovial sarcoma and certain genetically-defined solid tumors.
“Over the coming months, we have multiple anticipated clinical data and regulatory milestones, and we are well underway with commercialization readiness activities to support the potential launch of tazemetostat and our transition to a commercial-stage organization,” he added.
Epizyme plans to conduct a global Phase 3 trial to support full approval of tazemetostat for epithelioid sarcoma, which it expects to begin in the second half of 2019.
