Gazyva Approved for CLL

The United States Food and Drug Administration (FDA) has approved Gazyva (obinutuzumab) for the treatment of chronic lymphocytic leukemia (CLL). Gazyva is indicated to be used in combination with chlorambucil for the treatment of previously untreated CLL.

CLL is a type of leukemia, or cancer that starts in the immune cells. Typically, CLL is slow-growing, particularly in the early stages of the disease. There are many therapeutic options for CLL at present, based upon the stage, aggressiveness, prior therapies and other existing medical issues among patients.

Gazyva is a type of targeted therapy. It is a glycoengineered antibody against CD20. CD 20 is a type of molecule that is found on B-cells, or the type of immune cells that are cancerous with CLL. Through this binding, biochemical reactions occur that mitigate the replication and growth of the cancerous cells.

The trial that led to the approval of Gazyva included 356 patients with CLL who had not received prior therapy for their disease. One group of patients was treated with Gazyva plus chlorambucil and the other group of patients was treated with chlorambucil only.

Patients treated with Gazyva/chlorambucil had a significant improvement survival with no progression of their disease (progression-free survival) compared to those treated with chlorambucil only.
Progression-free survival was 23 months for those treated with Gazyva/chlorambucil, and 11.1 months for those treated with chlorambuci alone.
The most common side effects were infusion-related events, low levels of blood cells (white and red blood cells as well as platelets), bone and muscle pain and fever.
Patients diagnosed with CLL now have a new treatment alternative available to them and may wish to speak with their physician regarding their individual risks and benefits of all therapeutic approaches.

Reference: United States Food and Drug Administration (FDA). FDA approves Gazyva for chronic lymphocytic leukemia. Available at: . Accessed November 7, 2013