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Epizyme's New Drug Application for Tazemetostat Accepted by FDA

NEW YORK – Biopharma company Epizyme said on Friday that its new drug application for the accelerated approval of tazemetostat (Tazverik) to treat patients with relapsed or refractory follicular lymphoma was accepted by the US Food and Drug Administration. The intended use will be for patients who have previously received at least two lines of therapies.

The FDA classified this application as a supplemental NDA and has granted it priority review. Last month, the FDA approved tazemetostat for the treatment of patients with advanced epithelioid sarcoma who are ineligible for surgery. 

Tazemetostat, an oral inhibitor of the gene EZH2, is being studied as a monotherapy for molecularly defined solid tumors such as INI1-negative epithelioid sarcoma. In follicular lymphoma, the company is looking at the responses of patients with and without EZH2 activating mutations.

Epizyme's sNDA submission is supported by data from an updated Phase II trial presented at the 2019 American Society of Hematology meeting. The objective response rate to tazemetostat was 69 percent for patients with an EZH2 mutation, and 35 percent for patients with wild-type EZH2. The median duration of response was 11 months for patients with the mutation and 13 months for patients without. The median progression-free survival was 14 months for patients with the mutation and 11 months for patients with the wild-type gene. At the data cut-off date, no overall survival has been reached for either patient group.

Additionally, the company reported that favorable safety and tolerability were observed during the trial, and only 8 percent of patients discontinued treatment due to related adverse events. No treatment-related deaths have been reported.

Epizyme CEO Robert Bazemore said in a statement last year that if tazemetostat is approved, it would be the first-in-class EZH2 inhibitor for patients with follicular lymphoma.