FDA approves cobas EZH2 Mutation Test as companion diagnostic for Tazverik in follicular lymphoma.- Roche

Roche announced FDA approval of the cobas EZH2 Mutation Test as a companion diagnostic for Tazverik (tazemetostat), developed by Epizyme, Inc. This 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.

In a clinical trial, in patients diagnosed with relapsed/refractory FL who tested positive for defined mutations of the EZH2 gene, treatment with Tazverik showed significant benefit. Test samples are processed using the cobas DNA Sample Preparation Kit for DNA extraction from formalin-fixed paraffin-embedded (FFPE) human FL tumour tissue and the cobas z 480 Analyzer for automated amplification and detection. Results can be available in less than a day. The cobas EZH2 Mutation Test is expected to be commercially available in the U.S. later this year.