The FDA has approved Roche/Genentech‘s Gazyva (obinutuzumab), in combination with chlorambucil chemotherapy for the treatment of people with previously untreated chronic lymphocytic leukemia (CLL). Gazyva is the first medicine approved with the FDA’s Breakthrough Therapy Designation and the fifth cancer medicine from Genentech approved by the FDA in the past three years.

The FDA granted Gazyva Breakthrough Therapy Designation due to the significance of the positive progression-free survival (PFS) results from the Phase III CLL11 trial and the serious and life-threatening nature of CLL.

The CLL11 trial showed that people who received Gazyva in combination with chlorambucil chemotherapy had significantly reduced risk of disease progression or death compared to those who received chlorambucil alone (median PFS 23.0 months vs. 11.1 months). The most common Grade 3/4 adverse events for those who received Gazyva in combination with chlorambucil compared to chlorambucil alone were infusion-related reactions during the first infusion, low platelet count (thrombocytopenia, 11% vs. 3%) and low count of certain types of white blood cells (neutropenia, 34% vs. 16%), though this did not result in an increased rate of infections in the Gazyva arm.