Epizyme Reports FDA’s Acceptance of NDA for Tazemetostat to Treat Epithelioid Sarcoma

Shots:

• The NDA submission is based on P-II study assessing tazemetostat in 62 patients with epithelioid sarcoma resulted in durable response and was well tolerated. The US FDA has granted PR designation to the NDA with its expected PDUFA date as Jan 23, 2020
• The company plans the onset of a clinical study evaluating tazemetostat in combination with doxorubicin vs PBO in 150 patients with epithelioid sarcoma with its anticipated initiation in H2’19
• Tazemetostat is an oral EZH2 inhibitor, being evaluated as monothx. for solid tumors including epithelioid sarcoma, INI1-negative tumors and follicular lymphoma with/out EZH2 mutation

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