Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

Genentech's Obinutuzumab Gets Priority Review For Chronic Lymphocytic Leukemia

The U.S. Food and Drug Administration or FDA has accepted Genentech's Biologics License Application or BLA for obinutuzumab or GA101 and granted Priority Review in the treatment of chronic lymphocytic leukemia or CLL, one of the most common forms of blood cancer, based on final Stage 1 data from the pivotal CLL11 study. This acceptance follows the GA101 FDA Breakthrough Therapy Designation, received in May 2013. The FDA confirmed that the action date is December 20, 2013.

The FDA is assessing data from the pivotal Phase III CLL11 study, which found that GA101 showed a statistically significant 86 percent reduction in the risk of disease worsening or death when combined with chlorambucil chemotherapy compared to chlorambucil alone in previously untreated people with CLL and co-existing medical conditions. In CLL11, no new safety signals were detected for GA101.

GA101, an investigational medicine designed to attack cells that have a certain marker on their surface, is currently being investigated in a large clinical program, including multiple head-to-head Phase III trials versus rituximab in indolent non-Hodgkin's lymphoma and diffuse large B-cell lymphoma. CLL is one of the most common forms of blood cancer and in 2013, it is anticipated that there would be about 5,000 deaths from CLL in the U.S.

Genentech, a member of the Roche Group (RHHBY.PK), has headquarters in South San Francisco, California.

Register
To receive FREE breaking news email alerts for Roche Holding AG and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Swiss drug maker Roche Holding said a late-stage trial of its breast cancer drug Kadcyla did not provide superior results compared with an existing therapy. FCA US, until recently known as Chrysler, said Friday it is recalling 257,000 Dodge Ram pickups. The auto maker says the rear axle pinion nut on certain model year 2005 Dodge Ram 1500 trucks may loosen due to an undersized spline on the pinion gear. If the pinion nut loosens, the rear axle may... This medical device company has a very impressive track record of growing business over the past decade. increasing sales from $490.2 million in 2004 to $1.72 billion this year. The Silicone Hydrogel daily disposable lens portfolio constitutes a major avenue for growth.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.