FDA approves Gazyva (Genentech) for CLL

Genentech, has announced that the FDA approved Gazyva (obinutuzumab), also known as GA 101, 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 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).>