logo
Plus   Neg
Share
Email

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.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Facebook has unveiled Instagram Reels as its answer to the popular Chinese-owned video app TikTok. The social media giant said in a blog post that Instagram Reels is a new way to create short, entertaining videos on Facebook's photo-sharing app Instagram. Facebook reportedly shut down its TikTok clone Lasso in July, ahead of the launch of Instagram Reels. WD-40 Company recalled about 130,000 units of X-14 Mildew Stain Remover for potential risk of skin irritation, a statement by the U.S. Consumer Product Safety Commission (CPSC) showed. The company said pressure can build up inside the bottle and cause it to fall over and leak, posing a risk of skin irritation. Biopharmaceutical company Bristol-Myers Squibb Co. on Thursday reported a loss for the second quarter, compared to a profit last year, hurt primarily by hefty amortization expenses. However, adjusted earnings per share and quarterly revenues topped analysts' expectations. Looking ahead, the company raised its adjusted earnings and revenue outlook for the full-year 2020.
Follow RTT