Tazverik filed with FDA and given accelerated approval for follicular lymphoma.- Epizyme

Epizyme announced that the FDA has accepted for filing the company’s New Drug Application (NDA) for the accelerated approval of Tazverik (tazemetostat) for patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior lines of systemic therapy. The FDA granted Priority Review and has designated the company’s application as a supplemental NDA (sNDA) with a Prescription Drug User Fee Act (PDUFA) target action date of June 18, 2020. Priority Review is granted to investigational therapies that, if approved, may offer significant improvements in the treatment, prevention or diagnosis of a serious condition. Epizyme’s sNDA submission is based primarily on updated Phase II efficacy and safety data for Tazverik in this patient population, which were presented at the 2019 American Society of Hematology (ASH) Annual Meeting. The data demonstrated that treatment with Tazverik resulted in clinical benefit as assessed by both investigators and an Independent Review Committee (IRC), and was shown to be generally well tolerated in FL patients with EZH2 activating mutations (n=45) and FL patients with wild-type EZH2 (n=54). To support a full approval of Tazverik for FL, Epizyme is conducting a single, global, randomized, adaptive trial to evaluate the combination of Tazverik with “R2” (Revlimid plus Rituxan), an approved chemo-free treatment regimen, for FL patients in the second-line or later treatment setting. The trial is expected to enroll approximately 500 FL patients, stratified based on their EZH2 mutation status. The safety run-in portion of the trial is underway, and the company expects to advance into the efficacy portion of the Phase Ib/III trial in 2020.