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Roche : FDA Oks Cobas EZH2 Mutation Test As Companion Diagnostic For Follicular Lymphoma

Roche said that the U.S. Food and Drug Administration has approved the cobas EZH2 Mutation Test as a companion diagnostic for TAZVERIK or tazemetostat, developed by Epizyme Inc. The cobas EZH2 Mutation Test is expected to be commercially available in the U.S. later this year.

The molecular test detects abnormalities in the EZH2, or Enhancer of Zeste Homolog 2, gene in patients with follicular lymphoma (FL), 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 results can be available in less than a day, aiding clinicians in making timely decisions for effective treatment options that have the potential to prolong patient lives.

More than 15,000 new cases of follicular lymphoma are diagnosed each year in the US, and about 20 percent of patients will relapse within two years, with few treatment option.

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