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
Ciena Corp., a provider of communications networking solutions, on Thursday reported a turnaround to profit in the fourth quarter on higher revenues and lower expenses. However results for the quarter missed analysts' estimates. Looking ahead, the company forecast revenue for the first quarter of fiscal 2017 in line with analysts' expectations. Wearable fitness device maker Fitbit Inc. said it has acquired the assets of struggling smartwatch startup Pebble, including key personnel and intellectual property related to software and firmware development. The acquisition excludes Pebble's hardware products. Financial terms of the deal were not disclosed. Starbucks is teaming up with Pokémon Go, a location based augmented reality game, to turn its stores into PokéStops and Gyms, reports said. Further, the coffee giant reportedly would open Italian bakeries that serve pizza, with the first store expected to open in late 2017.
comments powered by Disqus
Follow RTT