The regulator has accepted the firm’s new drug application (NDA) for the accelerated approval of tazemetostat to treat patients with relapsed or refractory FL who have secured at least two prior lines of systemic therapy.
The FDA granted priority review, as well as designated Epizyme’s application as a supplemental NDA (sNDA).
Tazverik is a methyltransferase inhibitor designated for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
Epizyme has submitted the sNDA based on Tazverik’s updated phase 2 efficacy and safety data in this patient population.
According to the company, the data showed that treatment with Tazverik resulted in clinical benefit as measured by both investigators and an Independent Review Committee (IRC).
For the complete approval of Tazverik for FL, the firm is carrying out a single, global, randomised and adaptive study to assess the combination of Tazverik with “R2” (Revlimid plus Rituxan).
The “R2” is an approved chemo-free treatment regimen for FL patients in the second-line or later treatment setting.
Epizyme intends to recruit up to 500 FL patients in the trial, and they will be stratified based on their EZH2 mutation status. It aims to advance the trial into the efficacy portion of the Phase 1b/3 trial in 2020.
Last month, Epizyme secured accelerated approval from the FDA for Tazverik to treat patients epithelioid sarcoma.
Epizyme CEO Robert Bazemore 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.”