Roche Gets FDA Approval for Cobas EZH2 Mutation Test

Roche said U.S. Food and Drug Administration approved cobas EZH2 mutation test as a companion diagnostic for TAZVERIK (tazemetostat), developed by Epizyme, Inc.

• The molecular test detects abnormalities in the EZH2, or Enhancer of Zeste Homolog 2, gene in patients with follicular lymphoma, a type of non-Hodgkin lymphoma patients who may be eligible for treatment with TAZVERIK, a cancer drug that acts as a selective EZH2 gene inhibitor
• The test is expected to be commercially available in the U.S. later this year

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