FDA Approves Leukemia Drug Obinutuzumab (Gazyva)
Treatment is first with breakthrough designation to receive agency nod (November 1)
The FDA has approved obinutuzumab (Gazyva, Genentech) for use in combination with chlorambucil to treat patients with previously untreated chronic lymphocytic leukemia (CLL).
CLL is a blood and bone-marrow disease that usually gets worse slowly. According to the National Cancer Institute, 15,680 Americans will be diagnosed and 4,580 will die from the disease this year.
Obinutuzumab works by helping certain cells in the immune system attack cancer cells. It is intended to be used with chlorambucil.
Obinutuzumab is the first drug with a breakthrough therapy designation to receive FDA approval.
The approval of Gazyva (obinutuzumab) for CLL was based on results from a randomized open-label trial that compared obinutuzumab and chlorambucil with chlorambucil alone in 356 subjects with previously untreated CLL. Subjects receiving obinutuzumab in combination with chlorambucil demonstrated a significant improvement in progression-free survival compared with chlorambucil monotherapy (an average of 23.0 months vs. 11.1 months, respectively).
Gazyva (obinutuzumab) was approved with a boxed warning regarding hepatitis B virus reactivation and progressive multifocal leukoencephalopathy. These are known risks with other monoclonal antibodies in this class, and rare cases were identified in participants in other trials of obinutuzumab.
Source: FDA, November 1, 2013.