Epizyme has submitted a New Drug Application (NDA) for accelerated approval of tazemetostat for the treatment of patients with metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery.
Tazemetostat is an oral, first-in-class small molecule inhibitor of EZH2, a histone methyltransferase (HMT) enzyme with oncogenic activity. The NDA submission is based on updated tazemetostat efficacy and safety data from an ongoing phase 2 study cohort involving 62 epithelioid sarcoma patients, which will be presented at the American Society of Clinical Oncology (ASCO) 2019 Annual Meeting.
The Company plans to start a global, randomized controlled trial to support full approval of tazemetostat for epithelioid sarcoma in the second half of 2019. Details of this trial will be released once it has reached alignment with the FDA and the NDA submission has been accepted for review.
“If approved, we believe tazemetostat has the potential to change the care of patients with this disease,” said Dr Shefali Agarwal, chief medical officer of Epizyme. “We look forward to continuing to engage with the FDA as we work to bring tazemetostat to patients and physicians in the US.”
Epithelioid sarcoma is an ultra-rare soft tissue sarcoma characterized by a loss of the protein INI1.
For more information visit Epizyme.com.