In June 2020, the FDA approved tazemetostat (Tazverik) for 2 distinct follicular lymphoma indications based on overall response rate and duration of response observed in phase 2 clinical trial cohorts of patients with follicular lymphoma with EZH2 mutations and wild-type EZH2.
Novartis announced that the study met its primary end point of complete response rate in patients with relapsed or refractory follicular lymphoma.
The FDA approved tazemetostat for adult patients with relapsed or refractory FL whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies, as well as for adult patients with relapsed or refractory FL who have no satisfactory alternative treatment options.