FDA grants priority review to Tazverik for relapsed, refractory follicular lymphoma
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The FDA granted priority review to tazemetostat for the treatment of patients with relapsed or refractory follicular lymphoma.
Tazemetostat (Tazverik, Epizyme) — a methyltransferase inhibitor — already is approved in the United States for treatment of patients aged 16 years or older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
Epizyme seeks accelerated approval of the agent for treatment of patients with follicular lymphoma who received at least two prior lines of systemic therapy.
The supplemental new drug application is based primarily on data from a phase 2 study that evaluated the efficacy and safety of tazemetostat for this patient population. The results, presented at last year’s ASH Annual Meeting, showed tazemetostat conferred clinical benefit and appeared generally well-tolerated by patients with follicular lymphoma who had EZH2 activating mutations and those with EZH2 wild-type disease.
The FDA set a target action date for this application of June 18.
“Follicular lymphoma is an incurable disease for which patients are in need of a safe, durable treatment option,” Shefali Agarwal, MD, chief medical officer of Epizyme, said in a company-issued press release. “If approved, we believe Tazverik could become an important new option for these patients and their physicians.”
Epizyme is conducting a randomized, adaptive trial to evaluate tazemetostat in combination with lenalidomide (Revlimid, Celgene) and rituximab (Rituxan; Genentech, Biogen) as second-line or later treatment for follicular lymphoma.
The trial is designed to enroll about 500 patients who will be stratified by EZH2 status. The safety portion is underway, the efficacy portion is expected to begin later this year.