New Drug Gazyva Receives FDA Nod to Treat Chronic Lymphocytic Leukemia

The U.S. Food and Drug Administration has approved a new Roche drug called 'Gazyva' in combination with another anti-cancer drug to treat patients with untreated chronic lymphocytic leukemia (CLL).

In a latest announcement, the FDA said that it has approved Gazyva (obinutuzumab) to be used in combination with chlorambucil to treat with patients with untreated CLL. Gazyva is the first with breakthrough therapy designation to receive clearance from FDA.  The drug works by helping immune-system cells fight cancer cells.

"Today's approval represents an important new addition to the treatments for patients with CLL," Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said in a press release. "This approval reflects the promise of the Breakthrough Therapy Designation program, allowing us to work collaboratively with companies to expedite the development, review and availability of important new drugs."

The drug was granted a priority review as it demonstrated the potential to be a significant improvement in safety or effectiveness in treatment of serious condition. It was also given 'orphan product designation' as it is meant to treat only a rare disease.

The product gained FDA's approval after its efficacy was tested on 356 participants in a randomized trial. In the study, researchers compared compared Gazyva in combination with chlorambucil to chlorambucil alone in participants with previously untreated CLL. They noticed that participants who were givem Gazyva along with chlorambucil had high chances of progression-free survival, which was  an average of 23 months when compared to the 11 months of those who were treated with just chlorambucil.

The intake of this drug  when combined with chlorambucil triggered common side effects such as infusion-related reactions, a drop in white blood cells, low platelet count in blood, low red blood cells,  pain in the muscles as well as bones and fever.

The drug carries a boxed warning regarding Hepatitis B virus reactivation and a rare disorder that damages the material that blankets the nerves in white matter of the brain. Patients should be advised of these risks and assessed for Hepatitis B virus and reactivation risk.