Dr. Skarbnik on the Approval of Tazemetostat in Relapsed/Refractory Follicular Lymphoma

Alan P. Z. Skarbnik, MD, a hematologist/oncologist with Novant Health, highlights the approval of tazemetostat (Tazverik) in relapsed/refractory follicular lymphoma. 

Tazemetostat is a selective EZH2 inhibitor that was previously approved for ​locally advanced or metastatic epithelial sarcoma, ​says Skarbnik.

On June 18, 2020, ​the FDA granted an accelerated approval ​to tazemetostat for patients with EZH2-positive relapsed/refractory follicular lymphoma who have received at least 2 prior lines of therapy, says Skarbnik. 

The approval was based on results from 2 cohorts of a phase 2 trial (NCT01897571) that included patients with EZH2-mutated follicular lymphoma and EZH2 wild-type follicular lymphoma, ​Skarbnik explains. To date, there are no phase 3 studies with tazemetostat to compare historical standards with.

Notably, ​the EZH2 molecule can be mutated or upregulated in a small number of cases; however, there is currently no available assay that can be used to evaluate EZH2 upregulation, Skarbnik concludes.