A new drug application (NDA) has been submitted to the FDA for tazemetostat as a treatment for patients with relapsed/refractory follicular lymphoma, with or without EZH2 activating mutations, who have received ≥2 prior lines of systemic therapy.1
The submission, which is for an accelerated approval, is mostly based on updated results of an ongoing phase II trial, which showed that the first-in-class EZH2 inhibitor elicited an objective response rate (ORR), assessed by an independent review committee (IRC), of 69% for patients with EZH2-mutant disease and a 35% ORR for those with wild-type EZH2 follicular lymphoma.2 The IRC-assessed complete response (CR) and partial response (PR) rates were 13% and 56% in those with EZH2 mutations and 4% and 31% for patients with wild-type EZH2, respectively.
“We are very pleased to have submitted this NDA in hopes of bringing tazemetostat to [follicular lymphoma] patients and their physicians,” Shefali Agarwal, MD, chief medical officer of Epizyme, the developer of tazemetostat, stated in a press release. “[Follicular lymphoma] remains a devastating and incurable disease. We believe that if approved, the durable responses and favorable safety observed in patients both with and without an EZH2 activating mutation support tazemetostat’s potential to make a meaningful difference for these patients.”
The NDA submission follows a previous meeting Epizyme held with the FDA in October 2019, in which the agency indicated that it considered the proposed clinical package to be sufficient for inclusion as part of application for accelerated approval, the company stated in the press release. The agency has a review period of 60 days to determine whether the NDA submission is complete and suitable for filing.