Epizyme announces FDA acceptance of new drug application for filing with priority review for Tazverik (tazemetostat) for the treatment of follicular lymphoma


14 February 2020 - Approval would expand Tazverik label into second indication.

Epizyme today announced that the U.S. FDA has accepted for filing the company’s new drug application for the accelerated approval of Tazverik (tazemetostat) for patients with relapsed or refractory follicular lymphoma who have received at least two prior lines of systemic therapy. 

The FDA granted priority review and has designated the company’s application as a supplemental new drug application with a Prescription Drug User Fee Act target action date of 18 June 2020.

Read Epizyme press release

Michael Wonder

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Michael Wonder