The U.S. Food and Drug Administration has announced that obinutuzumab (GA101) has been accepted for priority review for the treatment of chronic lymphocytic leukemia (CLL) with the confirmed action date of December 20. The investigational drug is a glycoengineered, type 2 anti-CD20 monoclonal antibody.
The FDA is evaluating data from the Phase III CLL11 trial, which found that for patients with previously untreated CLL obinutuzumab reduced the risk of death or worsening of disease by 86 percent when combined with chlorambucil chemotherapy compared with the chemotherapy alone.
No new safety signals were detected for obinutuzumab in the trial. The most common grade 3 and 4 adverse events for the drug were infusion-related reactions and neutropenia, which did not result in increased infection rates.
The FDA's priority review designation shortens the time to complete a drug's review and aims to deliver a decision on marketing approval designation for drugs that may offer major advances in treatment or provide a treatment where no adequate therapy exists within six months under the Prescription Drug User Fee Act.
Obinutuzumab is being developed and marketed by Genentech.