|Brand name(s), other common name(s)||GazyvaTM|
|Drug type||Monoclonal antibody|
|How the drug is given||Intravenously (IV)|
Obinutuzumab is FDA-approved in combination with chlorambucil chemotherapy for the treatment of people with previously untreated chronic lymphocytic leukemia (CLL).
The FDA approval is based on the outcomes of the CLL11 trial. The trial showed that people who received Gazyva in combination with chlorambucil chemotherapy had significantly reduced risk of disease progression or death (HR=0.16; p<0.0001) and lived significantly longer without their disease getting worse compared to those who received chlorambucil alone (median PFS 23.0 months vs. 11.1 months).
Side effects needing medical attention:Infusion-related reactions during the first infusion; low platelet count; low red blood cell counts; fever; cough; muscle and joint pain; low count of certain types of white blood cells.
Progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection that can result in death, has been reported with obinutuzumab.
Hepatitis B virus (HBV) reactivation may cause serious liver problems including liver failure and death. If patients have had hepatitis B or are carriers of HBV, receiving obinutuzumab could cause the virus to become an active infection again.