Epizyme Inc. is seeking accelerated U.S. Food and Drug Administration approval for its drug tazemetostat as a treatment for a certain kind of blood cancer.
The Cambridge, Mass.-based drugmaker filed a new drug application for tazemetostat for treating patients with relapsed or refractory follicular lymphoma — a cancer that affects white blood cells — and who have received at least two prior lines of systemic therapy.
The lymphoma can be with or without EZH2 activating mutations.
The application is based on a mid-stage study of the drug for patients with the disease, where the therapy showed clinical benefit and was also well-tolerated among follicular lymphoma patients.
The submission also follows a pre-new drug application meeting with the U.S. regulator in October, where the agency indicated it considered the proposed clinical package as sufficient for accelerated approval.
To support a full approval for the indication, Epizyme is conducting a single, global, randomized trial evaluating tazemetostat with Revlimid and Rituxan for follicular lymphoma patients as a second-line or later treatment.
The U.S. FDA is expected to decide whether or not to accept the submission for review within 60 days.
A panel of outside advisers to the U.S. FDA also recently voted unanimously to approve tazemetostat for treating epithelioid sarcoma.