Genentech submits sBLA for Avastin’s use in glioblastoma treatment

Genentech, Inc. has submitted an application to the U.S. Food and Drug Administration  for its product Avastin® as a therapy for patients of glioblastoma who have received a treatment previously. If the supplemental Biologics License Application (sBLA) is accepted by the FDA, the drug can be considered for a provisional approval for treatment of cancer and other such deadly diseases. Glioblastoma is the most aggressive form of brain cancer. It has no cure. The study found that Avastin, when as evaluated as a single agent, showed that 43 percent of patients experienced no progression of disease.

Rituxan fails to meet primary endpoint in Phase II/III study for PMS

Genentech and Biogen Idec’s Phase II/III study of Rituxan (rituximab) on patients suffering from primary-progressive multiple sclerosis failed to meet its primary endpoint, which was the time to confirmed disease progression during the 96-week treatment period. The randomized, double-blind, placebo-controlled, multi-center study evaluated the efficacy, safety and tolerability of four courses of Rituxan in 439 patients. Most events in the Rituxan arm were mild to moderate and the overall adverse event rates for the drug were 16.4%, as compared to 13.6% for placebo.