FDA Approves Obinutuzumab for CLL
- By BSTQ Staff
The U.S. Food and Drug Administration (FDA) has approved obinutuzumab (Gazyva, Genentech) for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL). The drug is indicated for use in combination with chlorambucil. It is the first drug with a “breakthrough therapy” designation to receive FDA approval, which means it has the potential to offer a substantial improvement over available therapies for patients with serious or life-threatening diseases.
In the randomized multicenter Phase III trial of 356 patients with previously untreated CLL, those who received obinutuzumab in combination with chlorambucil had significantly better median progression-free survival than those treated with chlorambucil alone (23 months vs. 11.1 months). The most common adverse effects in patients receiving obinutuzumab were infusion-related reactions, neutropenia, thrombocytopenia, anemia, musculoskeletal pain and pyrexia. The drug is approved with a boxed warning about hepatitis B virus reactivation, as well as the drug’s risk of inducing progressive multifocal leukoencephalopathy. However, according to the FDA, these are known risks with other monoclonal antibodies in the class, and rare cases have been identified in participants in other trials of obinutuzumab.
