Epizyme Announces FDA Acceptance of New Drug Application for Filing with Priority Review for TAZVERIK™ (tazemetostat) for the Treatment of Follicular Lymphoma
Epizyme, Inc. (EPZM)
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Source: Business Wire
Approval Would Expand TAZVERIK™ Label into Second IndicationPDUFA Target Action Date Scheduled for June 18, 2020 CAMBRIDGE, Mass.--(BUSINESS WIRE)--Epizyme, Inc. (Nasdaq: EPZM), a fully integrated commercial-stage biopharmaceutical company developing novel epigenetic therapies, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the company’s New Drug Application (NDA) for the accelerated approval of TAZVERIK™ (tazemetostat) for patients with relapsed or refractory follicular lymphoma (FL) 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 NDA (sNDA) with a Prescription Drug User Fee Act (PDUFA) target action date of June 18, 2020. Priority Review is granted to investigational therapies that, if approved, may offer significant improvements in the treatment, prevention or diagnosis of a serious condition.“Follicular lymphoma is an incurable
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