Roche’s blood cancer drug receives FDA Priority Review
Swiss pharma company Roche has announced that its chronic lymphocytic leukemia drug has been granted Priority Review by the US Food and Drug Administration (FDA).
Chronic lymphocytic leukemia (CLL) is one of the most common forms of blood cancer. In May 2013, obinutuzumab received Breakthrough Therapy Designation from the FDA, which is designed to speed up the development and review of medicines that treat life-threatening diseases.
Roche’s Biologics License Application (BLA) was accepted based on final phase 3 clinical trial data, which found that obinutuzumab demonstrated a statistically significant 86% reduction in the risk of disease worsening or death when combined with chlorambucil compared to chlorambucil alone in previously untreated people with CLL and co-existing medical conditions.
“We’re excited that the FDA has granted GA101 in CLL both Breakthrough Therapy Designation and Priority Review. These FDA designations acknowledge the promising trial results with GA101 and will hopefully allow this novel medicine to reach the people who need it in an expedited time frame.”
Hal Barron, M.D., chief medical officer and head, Global Product Development.
The FDA confirmed that the Priority Review date for obinutuzumab is December 20th 2013.
The drug is currently also being investigated in clinical trials as a treatment for other diseases, including indolent non-Hodgkin’s lymphoma (NHL) and diffuse large B-cell lymphoma (DLBCL).
Yesterday, Roche subsidiary Genentech received FDA Priority Review status for a Perjeta (pertuzumab) regimen to be used before surgery (neoadjuvant treatment) in people with HER2-positive early stage breast cancer.
Don't miss your daily pharmaphorum news.
SUBSCRIBE free here.