FDA Approves Expanded Use of Epizyme’s Tazverik for Relapsed/Refractory Follicular Lymphoma

Rare Daily Staff

The U.S. Food and Drug Administration approved expanded use of Epizyme’s Tazverik to include relapsed or refractory follicular lymphoma, a rare cancer.

The approval is for use of Tazverik in patients with an EZH2 mutation as detected by an FDA-approved test, or for those who have received at least two prior systemic therapies, or for patients with relapsed or refractory follicular lymphoma who are without satisfactory treatment options.

“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,” said Shefali Agarwal, chief medical officer of Epizyme. “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.”

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 follicular lymphoma 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.

Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial or trials. Epizyme is conducting a single global, randomized, adaptive confirmatory trial to evaluate the combination of Tazverik with Revlimid plus rituximab, an approved chemo-free treatment regimen, for FL patients in the second-line or later treatment setting.

The trial is expected to enroll approximately 500 FL patients, stratified based on their EZH2 mutation status, and the safety run-in portion is underway. In addition, Epizyme will conduct post-marketing commitments, including expanding its phase 2 clinical trial cohort of FL patients with wild-type EZH2 who have been treated with at least one prior systemic treatment to enroll additional patients, in order to support a potential label expansion in the second-line relapsed and refractory setting in the future.

Photo: Shefali Agarwal, chief medical officer of Epizyme