FDA grants accelerated approval for Tazverik to treat follicular lymphoma. Epizyme Inc.

Epizyme, Inc. announced that the FDA has approved the supplemental New Drug Application (sNDA) for Tazverik (tazemetostat) for the following two distinct follicular lymphoma (FL) indications:1. Adult patients with relapsed or refractory FL whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies. 2.Adult patients with relapsed or refractory FL who have no satisfactory alternative treatment options.

These indications were approved under accelerated approval with a priority review, based on overall response rate and duration of response in the company’s Phase II clinical trial cohorts of FL patients with EZH2 mutations and wild-type EZH2. Tazverik received initial accelerated approval by FDA on January 23, 2020 for the treatment of adult and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.