FDA Approves Tazemetostat for R/R Follicular Lymphoma

On June 18, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tazemetostat (Tazverik, Epizyme, Inc.), an EZH2 inhibitor, for adult patients with relapsed or refractory (R/R) follicular lymphoma (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, and for adult patients with R/R FL who have no satisfactory alternative treatment options.

On the same day, the FDA also approved the cobas EZH2 Mutation Test (Roche Molecular Systems, Inc.) as a companion diagnostic for tazemetostat.

Read FDA announcement.

Posted 6/18/2020