logo
Share SHARE
FONT-SIZE Plus   Neg

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.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Tech giant Apple Inc. has developed a new technology that will prohibit audiences using their iPhones to record concerts. The Cupertino, California-based company has secured a patent in the US for its new technology. The technology uses infrared signals to shut down cameras on audience members' smartphones. The... Snacks giant Mondelez International Inc. (MDLZ) made a takeover bid of $23 billion to acquire chocolate behemoth Hershey Co. (HSY) that would create the world's largest chocolate company. Nevertheless, shares of Hershey jumped over 15 percent after the company revealed that it has rejected the offer. "The... Mortgage rates dropped this week to the lowest level in more than three years hurt by the UK's shocking decision to exit European Union. Releasing the results of its primary mortgage market survey, Freddie Mac said that the 30-year fixed-rate mortgage or FRM averaged 3.48 percent for the week ended...
comments powered by Disqus
Follow RTT