INDIANAPOLIS, June 19, 2020 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBF) today announced U.S. Food and Drug Administration (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 benefit2.
"The approval of the cobas EZH2 Mutation Test underscores Roche's personalised healthcare strategy to provide innovative diagnostic tools for physicians and their patients," said John Palma, Chief Medical Officer of Roche Sequencing Solutions. "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."
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.
About the cobas EZH2 Mutation Test
The cobas EZH2 Mutation Test3 is a real-time allele-specific polymerase chain reaction (PCR) test for qualitative detection of single nucleotide mutations for Y646N, Y646F or Y646X (Y646H, Y646S, or Y646C), A682G, and A692V of the EZH2 gene in DNA extracted from formalin fixed paraffin embedded (FFPE) human follicular lymphoma tumor tissue specimens. The cobas EZH2 Mutation Test is intended for the identification of follicular lymphoma patients with an EZH2 mutation for treatment with TAZVERIK™ (tazemetostat), in accordance with the approved therapeutic product labeling.
TAZVERIK is a methyltransferase inhibitor indicated for the treatment of:
- Adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
- Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies.
- Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options.
These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
The most common (≥20%) adverse reactions in patients with epithelioid sarcoma are pain, fatigue, nausea, decreased appetite, vomiting, and constipation. The most common (≥20%) adverse reactions in patients with follicular lymphoma are fatigue, upper respiratory tract infection, musculoskeletal pain, nausea and abdominal pain.
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 American Journal of Managed Care, May 31, 2019
 Morschhauser et al, Oral Presentation, American Society of Hematology (ASH) Annual Meeting, Dec 2019
 cobas EZH2 Mutation Test package insert
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SOURCE Roche Diagnostics