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