The FDA granted a priority review to the new drug application (NDA) for tazemetostat for the treatment of patients with relapsed or refractory follicular lymphoma who have received at least two prior lines of systemic therapy.
The NDA is supported by updated data from the phase II trial of tazemetostat, a methyltransferase inhibitor, in which the agent demonstrated clinical activity in patients with follicular lymphoma with or without the EZH2 mutation. An ongoing randomized trial evaluating lenalidomide plus rituximab with or without tazemetostat as second-line or later treatment is underway.
Tazemetostat was previously approved for the treatment of patients with metastatic or locally advanced epithelioid sarcoma who are not eligible for complete resection.
The target action date for the application is June 18, 2020.
Source: Epizyme press release, February 14, 2020.