Roche receives FDA approval for cobas EZH2 Mutation Test as a companion diagnostic for patients with follicular lymphoma

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. 

About TAZVERIK
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.

About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people's lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
[1] American Journal of Managed Care, May 31, 2019
[2] Morschhauser et al, Oral Presentation, American Society of Hematology (ASH) Annual Meeting, Dec 2019
[3] cobas EZH2 Mutation Test package insert

Roche Diagnostics US Media Relations
Mike Weist
1 317 371 0035 // [email protected]

Roche Molecular Solutions Media Relations
Elizabeth Baxter
1 925 523 8812 // [email protected]

SOURCE Roche Diagnostics