The FDA granted a priority review to the new drug application (NDA) for the accelerated approval of tazemetostat (Tazverik) for patients with relapsed or refractory follicular lymphoma who have received at least 2 prior lines of systemic therapy, according to Epizyme, the agent’s developer.
The agency set a Prescription Drug User Fee Act (PDUFA) target action date of June 18, 2020.
“Follicular lymphoma is an incurable disease or which patients are in need of a safe, durable treatment option,” Shefali Agarwal, MD, chief medical officer for Epizyme, said in a press release. “If approved, we believe Tazverik could become an important new option for these patients and their physicians. We are thrilled with (the) FDA’s acceptance of our application as a (supplemental) NDA with priority review, for Tazverik for patients with relapsed or refractory follicular lymphoma. We look forward to working with the Agency during their review and would like to thank the many patients, caregivers, and physicians whose contributions have been invaluable in bringing us to this point.”
The sNDA submission is primarily based on updated phase II efficacy and safety data for tazemetostat in this patient population. The data illustrated that treatment with tazemetostat resulted in clinical benefit, as assessed by both investigators and an Independent Review Committee (IRC), and was found to be generally well tolerated in patients with follicular lymphoma with EZH2 activating mutations (n = 45) and patients with follicular lymphoma who had wild-type EZH2 (n = 54).
Results from the trial were presented at the 61st American Society of Hematology (ASH) Annual Meeting & Exposition, held in Orlando, Florida, from December 7-10, 2019.
In order to obtain a full approval of tazemetostat for follicular lymphoma, the company is conducting a single, global, randomized, adaptive trial to evaluate the combination of tazemetostat with “R2” (lenalidomide [Revlimid] plus rituximab [Rituxan]), an approved chemo-free treatment regimen, for patients with follicular lymphoma who are in the second-line or later treatment setting. The trial is anticipated to enroll approximately 500 patients with follicular lymphoma, stratified based on their EZH2 mutation status. The safety run-in portion of the trial is already underway, and the company expects to progress into the efficacy portion of the phase Ib/III trial in 2020.
Tazemetostat is a methyltransferase inhibitor that is currently indicated for the treatment of those aged 16 years or older with metastatic or locally advanced epithelioid sarcoma who are not eligible for complete resection. This indication was approved under accelerated approval based on overall response rate and duration of response. However, continued approval for this indication could be contingent upon verification and description of clinical benefit in confirmatory trials.
Epizyme Announces FDA Acceptance of New Drug Application for Filing with Priority Review for TAZVERIK (tazemetostat) for the Treatment of Follicular Lymphoma [news release]. Cambridge, Massachusetts. Published February 14, 2020. epizyme.gcs-web.com/news-releases/news-release-details/epizyme-announces-fda-acceptance-new-drug-application-filing. Accessed February 14, 2020.