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The agency extends the indication of the drug in combination with bendamustine.
The European Medicines Agency (EMA) announced on April 29, 2016 that its Committee for Medicinal Products for Human Use (CHMP) recommends the extension of the authorized indication of Gazyvaro (obinutuzumab). CHMP recommends the use of Gazyvaro, in combination with bendamustine, to treat follicular lymphoma in patients previously treated with chemotherapy. The CHMP recommendation will be sent to the European Commission for potential marketing authorization throughout Europe.
The CHMP recommendation is based on results of a Phase III trial that compared the effects of Gazyvaro given in combination with bendamustine, followed by Gazyvara as a maintenance treatment, with the effects of treatment with bendamustine alone. Patients in the study who were treated with the combination of Gazyvara and bendamustine lived longer without disease progression compared to patients who were treated with bendamustine alone.
In July 2014, the European Union authorized Gazyvaro for use in combination with chlorambucil for the treatment of chronic lymphocytic leukemia. The drug’s active ingredient, a monoclonal antibody, targets B-lymphocytes and activates the immune system. According to EMA, “follicular lymphoma and chronic lymphocytic leukemia are both rare types of cancer that affect certain white blood cells that fight infection, called B-lymphocytes. In follicular lymphoma, the body produces abnormal B cells that build up in lymph nodes.”