Roche gets FDA nod for cobas EZH2 Mutation Test as companion diagnostic for follicular lymphoma patients

Roche has secured approval from the US Food and Drug Administration (FDA) for its cobas EZH2 Mutation Test as a companion diagnostic for TAZVERIK (tazemetostat), developed by Epizyme.

According to the Swiss healthare company, the molecular test can detect abnormalities in the EZH2, or Enhancer of Zeste Homolog 2, gene in patients having follicular lymphoma (FL), a type of non-Hodgkin lymphoma patients who could be eligible for treatment with TAZVERIK, a cancer drug that plays the role of a selective EZH2 gene inhibitor.

In a clinical trial in patients diagnosed with relapsed/refractory follicular lymphoma who tested positive for defined mutations of the EZH2 gene, treatment with TAZVERIK showed considerable benefit.

John Palma – Chief Medical Officer of Roche Sequencing Solutions said: “The approval of the cobas EZH2 Mutation Test underscores Roche’s personalised healthcare strategy to provide innovative diagnostic tools for physicians and their patients.

“There have been few treatment options for patients with relapsed follicular lymphoma, and we are pleased to provide clinicians and their patients rapid and reliable results to help determine the best treatment options.”

As per Roche, the cobas EZH2 Mutation Test is anticipated to be available commercially in the US later this year.