U.S. Food and Drug Administration Approves Tazemetostat (TAZVERIK) and EZH2 Mutation Test for Follicular Lymphoma

On June 18, 2020, the U.S. Food and Drug Administration (FDA) announced it has granted accelerated approval of tazemetostat (TAZVERIK, Epizyme, Inc.), an EZH2 inhibitor, for adult patients with relapsed or refractory follicular lymphoma (FL) whose tumors are positive for an EZH2 mutation as detected by the EZH2 Mutation Test (Roche Molecular Systems, Inc.) and have received at least 2 prior systemic therapies; and for adult patients with relapsed or refractory FL who have no satisfactory alternative treatment options.

The EZH2 Mutation Test was also approved by the FDA on June 18, 2020 as a companion diagnostic for tazemetostat.

“Despite witnessing numerous advancements for people with blood cancer over the past several years, many patients diagnosed with follicular lymphoma must still contend with relapse or recurrence as well the challenge of adverse events,” said Meghan Gutierrez, Chief Executive Officer for the Lymphoma Research Foundation.  “For these reasons, and given that most patients manage their disease over a long time period, expanded treatment options can transform the patient experience and offer new hope.”

For more information on the FDA approval of tazemetostat or the EZH2 Mutation Test, visit the FDA’s website.  For more information on FDA approved therapies for FL, visit lymphoma.org/FLFDAUpdates.


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