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Epizyme seeks accelerated US FDA approval for cancer drug

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Epizyme seeks accelerated US FDA approval for cancer drug

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.