FDA Approves New Leukemia Drug, Gazyva

The U.S. Food and Drug Administration (FDA) has recently approved a new cancer-fighting drug known as Gazyva. This drug can be used in combination with chlorambucil in order to treat patients with untreated chronic lymphocytic leukemia (CLL), according to a press release.

Chronic Lymphocytic Leukemia (CLL) is known as a bone marrow and blood disease that gradually worsens over time. Statistics show that as many as 15,680 Americans will be diagnosed with this health issue and as many as 4,580 will die from the disease each year.

The drug was marked by the company Roche as of Friday and became the first product with breakthrough therapy that received an FDA approval.

"Today's approval represents an important new addition to the treatments for patients with CLL," said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research. "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."

A clinical trial that involved 356 patients showed that in combination with chlorambucil, the medication provided better improvement of the health issue over the average of 23 months than 11.1 months of chlorambucil alone.

Various side effects of the drug include infusion related issues, such as a decrease in white blood cells, pain in muscles and bones and fever. 

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