FDA Approves New Cancer Drug

The Food and Drug Administration has (FDA) approved a drug designed to help treat a type of blood and bone marrow cancer known as chronic lymphocytic leukemia (CLL).

The drug, called Gazyva, is to be used in combination with the medication chlorambucil in patients with previously untreated CLL.

According to the FDA, Gazyva works by helping certain cells in the immune system attack cancer cells and is the first drug with breakthrough therapy designation to receive FDA approval. The label is one the FDA can use should clinical trials suggest the drug offers "substantial improvement over available therapies for patients with serious or life-threatening diseases," according to a statement issued by the agency.

In a random study of 356 patients, participants receiving Gazyva in combination with chlorambucil had a median survival of 23 months before death, relapse or a worsening of their disease, compared to 11 months among those who received chlorambucil alone.

Gazyva also received priority review due to the fact that the drug demonstrated the potential of improving safety or effectiveness in the treatment of a serious condition.

"Today's approval represents an important new addition to the treatments for patients with CLL," said Dr. Richard Pazdur, 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."

The most common side effects seen in those receiving Gazyva were infusion-related reactions, a decrease in infection-fighting white blood cells, a low level of platelets in the blood, low red blood cells, pain in the muslces and bones and fever.

According to the National Cancer Institute, 15,680 individuals living in the United States will be diagnosed with CLL and 4,580 will die from the disease this year.

Gazyva is marketed by Genentech, a member of the Roche Group.