Research & Development
Epizyme files TAZVERIK NDA under FDA's Priority Review for follicular lymphoma
17 February 2020 -

Biopharmaceutical company Epizyme Inc (Nasdaq:EPZM) revealed on Friday that it has filed its New Drug Application (NDA) for the accelerated approval of TAZVERIK (tazemetostat) for patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior lines of systemic therapy under the US Food and Drug Administration's (FDA) Priority Review.

According to the company, TAZVERIK is a methyltransferase inhibitor that was previously indicated for the treatment of adults and paediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.

The US FDA has designated the company's application as a supplemental NDA (sNDA) with a Prescription Drug User Fee Act (PDUFA) target action date of 18 June 2020.

This NDA submission is based on the company's updated Phase 2 efficacy and safety data for TAZVERIK in this patient population. The treatment with TAZVERIK resulted in clinical benefit as assessed by both investigators and an Independent Review Committee (IRC) and was shown to be generally well tolerated in FL patients with EZH2 activating mutations and FL patients with wild-type EZH2.

To support a full approval of TAZVERIK for FL, the company will launch a single, global, randomized, adaptive trial to evaluate the combination of TAZVERIK with "R2" (Revlimid plus Rituxan), an approved chemo-free treatment regimen, for FL patients in the second-line setting. The safety run-in portion is underway and it expects to advance into the efficacy portion of the Phase 1b/3 trial in 2020.