Epizyme gets FDA priority review for TAZVERIK in follicular lymphoma
Epizyme has been granted priority review by the US Food and Drug Administration (FDA) for the use of TAZVERIK (tazemetostat) in relapsed or refractory follicular lymphoma (FL).
As per the new drug application (NDA) that has been accepted by the FDA, the Massachusetts-based biopharma company is seeking the accelerated approval of the methyltransferase inhibitor for the treatment of the disease in patients who had been given two or more prior lines of systemic therapy.
Follicular lymphoma is a cancer that affects the white blood cells.
Commenting on the TAZVERIK FDA priority review, Dr. Shefali Agarwal – chief medical officer of Epizyme said: “Follicular lymphoma is an incurable disease for which patients are in need of a safe, durable treatment option.
“If approved, we believe TAZVERIK could become an important new option for these patients and their physicians. We are thrilled with FDA’s acceptance of our application as an sNDA with Priority Review, for TAZVERIK for patients with relapsed or refractory FL.”
TAZVERIK already has FDA accelerated approval for the treatment of metastatic or locally advanced epithelioid sarcoma in adults and pediatric patients, aged 16 years and older who are not eligible for complete resection.
Epizyme said that the Prescription Drug User Fee Act (PDUFA) target action date given by the FDA to decide on the approval of the methyltransferase inhibitor in follicular lymphoma is 18 June 2020.
An FDA priority review is given to investigational therapies that, if approved, could offer substantial improvements in the treatment, prevention, or diagnosis of a serious condition.
Epizyme gets FDA priority review for TAZVERIK in follicular lymphoma. Photo courtesy of The U.S. Food and Drug Administration/Wikipedia.org.
Robert Bazemore – CEO of Epizyme, commenting on the TAZVERIK FDA priority review said: “On the heels of our first approval for TAZVERIK for epithelioid sarcoma last month and a successful launch into the market, this sNDA filing acceptance brings us one step closer to providing TAZVERIK to a larger patient population.
“The June 2020 PDUFA date positions TAZVERIK for two FDA approvals within six months of each other, which would be a remarkable achievement for Epizyme. We are actively building off our experience with our ES commercial launch, in order to seamlessly expand to an FL launch where we anticipate rapid market adoption, if approved.”
The sNDA submission of Epizyme for follicular lymphoma is based mainly on updated phase 2 efficacy and safety data for the methyltransferase inhibitor in the patient population, which were unveiled at the 2019 American Society of Hematology (ASH) Annual Meeting. The data showed that treatment with TAZVERIK delivered clinical benefit as evaluated by investigators and an independent review committee (IRC), and was shown to be generally well tolerated in follicular lymphoma patients with EZH2 activating mutations (n=45) and FL patients with wild-type EZH2 (n=54).
To support a full FDA approval of TAZVERIK for follicular lymphoma, Epizyme is carrying out a single, global, randomized, adaptive trial to assess its combination with an approved chemo-free treatment regimen R2 (Revlimid plus Rituxan) for the treatment of patients in the second-line or later treatment setting.
The clinical trial is likely to enroll nearly 500 follicular lymphoma patients, who will be grouped based on their EZH2 mutation status. The safety run-in portion of the follicular lymphoma trial is in progress, and Epizyme expects to take it forward into the efficacy portion of the phase 1b/3 trial this year.