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FDA Grants Priority Review to Tazemetostat in Follicular Lymphoma

Jason M. Broderick
Published: Friday, Feb 14, 2020

Shefali Agarwal, MD, chief medical officer of Epizyme

Shefali Agarwal, MD

The FDA has granted a priority review designation to a supplemental new drug application (sNDA) for tazemetostat (Tazverik) for the treatment of patients with relapsed/refractory follicular lymphoma who have received at least 2 prior lines of systemic therapy.1

The sNDA 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.

Under the Prescription Drug User Fee Act, the FDA is scheduled to decide on the sNDA on or before June 18, 2020.

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