The FDA grants tazemetostat (EPZ-6438) Fast Track Designation for treatment of relapsed/refractory Follicular Lymphoma

On 25^th April 2017, tazemetostat (EPZ-6438), an orally administered, first-in-class, small molecule EZH2 inhibitor, was granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with R/R FL regardless of EZH2 mutation.

This is the second Fast Track Designation given to Epizyme’s tazemetostat; in January 2017 the Lymphoma Hub reported on the first Fast Track status for R/R DLBCL with EZH2-activating mutations.

Tazemetostat is being assessed as a single-agent and in combination in numerous clinical trials. Trials currently recruiting include a phase I trial of tazemetostat combined with atezolizumab in patients with R/R DLBCL (NCT02220842) and a phase I/II trial of tazemetostat combined with R-CHOP in older patients (60–80 years old) with newly diagnosed DLBCL (NCT02889523).

Moreover, Epizyme has announced that it will present interim effectiveness and safety data from 5 cohorts in an ongoing phase II trial in R/R FL and DLBCL at the 14th International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland, in June. Data from a biomarker study of tazemetostat in NHL patients will also be presented during the conference in a poster session.