Market Overview

FDA Grants Genentech's Obinutuzumab Priority Review for Previously Untreated CLL

Share:
Related RHHBY
Analyst Grows Cautious On Merck's Keytruda After Company Withdraws European Application
This Drug, An Alternative To Marijuana And Ketamine, Could Treat Suicidal Depression And PTSD
European advisory group thumbs down on Chugai's multiple myeloma med Aplidin (Seeking Alpha)

Genentech, a member of the Roche Group OTC: RHHBY),
today announced that the U.S. Food and Drug Administration (FDA) has
accepted the company's Biologics License Application (BLA) for

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

“We're excited that the FDA has granted GA101 in CLL both Breakthrough
Therapy Designation and Priority Review,” said Hal Barron, M.D., chief

See full press release

Posted-In: News Guidance Contracts FDA Management Global

 

Related Articles (RHHBY)

View Comments and Join the Discussion!

Partner Center