The U.S. Food and Drug Administration has approved a new cancer-fighting drug Gazyva which can be used in combination with chlorambucil to treat patients with untreated chronic lymphocytic leukemia (CLL).
Chronic Lymphocytic Leukemia (CLL) is a bone marrow and blood disease that worsens with time. According to statistics released earlier this month, 15,680 Americans will be diagnosed and 4,580 will die from the disease this year.
On Friday, Gazyva, a drug marketed by Roche became the first drug with breakthrough therapy designation to receive an FDA approval. The drug helps certain cells in the immune system attack cancer cells and is intended to be used in combination with chlorambucil, another drug used to treat CLL.
"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 was carried out on 356 participants. It was observed that participants who received Gazyva in combination with chlorambucil demonstrated a significant improvement in progression free survival - an average of 23 months compared to 11.1 months with chlorambucil alone.
The side effects of the drug include infusion-related reactions, a decrease in infection-fighting white blood cells (neutropenia), a low level of platelets in the blood (thrombocytopenia), low red blood cells (anemia), pain in the muscles and bones (musculoskeletal pain), and fever (pyrexia). The drug comes with a boxed warning label stating risks of Hepatitis B virus reactivation and a rare disorder that damages the material that covers and protects nerves in the white matter of the brain.
