Epizyme Announces U.S. FDA Accelerated Approval of TAZVERIK (tazemetostat) for Relapsed/Refractory Follicular Lymphoma

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 approved the supplemental New Drug Application (sNDA) for TAZVERIK (tazemetostat) for the following two distinct follicular lymphoma (FL) indications:

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• Adult patients with relapsed or refractory FL whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies.
• Adult patients with relapsed or refractory FL who have no satisfactory alternative treatment options.

These indications were approved under accelerated approval with a priority review, based on overall response rate and duration of response in the company’s Phase 2 clinical trial cohorts of FL patients with EZH2 mutations and wild-type EZH2. TAZVERIK received initial accelerated approval by FDA on January 23, 2020 for the treatment of adult and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.

“We are very pleased to be able to offer TAZVERIK as a treatment option for relapsed or refractory FL patients, which is the culmination of many years of work by our team,” said Dr. Shefali Agarwal, chief medical officer of Epizyme. “In our view, there remains no clear standard of care in the relapsed and/or refractory FL population as not all patients benefit from today’s available therapies. Based on this label, physicians will have the ability to use their clinical discretion to prescribe TAZVERIK for their relapsed or refractory patients regardless of EZH2 mutational status and without regard to a specific line of treatment where other options are not satisfactory. We are grateful to the many patients, physicians and medical teams who helped bring us to this important achievement.”

“Follicular lymphoma remains an incurable disease, and even with the availability of new drugs in recent years, there have remained important unmet needs in the treatment of follicular lymphoma,” said John P. Leonard, M.D., the Richard T. Silver Distinguished Professor of Hematology and Medical Oncology at Weill Cornell Medicine, an oncologist at NewYork-Presbyterian/Weill Cornell Medical Center, and an investigator in the Phase 1b/3 confirmatory trial for TAZVERIK for FL. “The durable responses observed with this drug are notable in the context of the safety profile and route of oral, at-home administration, and will offer an important new option for physicians as we care for patients with relapsed/refractory follicular lymphoma.”