On November 1, the Food and Drug Administration (FDA) announced the approval of Gazyva for the treatment of chronic lymphocytic leukemia. In addition, due to promising results of clinical trials, it was given the agency’s breakthrough therapy designation, marking the first drug with this designation to receive FDA approval.
The approval was granted for use of Gazyva (obinutuzumab) in combination with chlorambucil to treat patients that suffer from previously untreated chronic lymphocytic leukemia. The disease is a form of blood and bone marrow cancer that usually has a slow progression; it primarily affects older adults. According to the American Cancer Society, about 15,700 cases of chronic lymphocytic leukemia are expected to be diagnosed in 2013, and about 4,600 people will die of the disease.
Gazyva is one of a new breed of anti-cancer drugs that work by stimulating the immune system to recognize and attack cancer cells. Common side effects that occurred during clinical trials included anemia, decreased white blood cell count, fever, muscle aches, and bone pain.
The FDA approval of Gazyva was based on a study of 356 individuals who participated in a multicenter clinical trial comparing Gazyva in combination with chlorambucil to chlorambucil alone. All the participants suffered from chronic lymphocytic leukemia that had not been previously treated. The patients who were given Gazyva in combination with chlorambucil experienced a significant improvement in progression free survival; it was an average of 23 months for these patients, compared to 11.1 months for the patients who received chlorambucil alone.
Gazyva is marketed by Genentech, based in South San Francisco, California. According to Genentech, the drug will cost $41,300 for one course of treatment, which lasts six months.
Chronic lymphocytic leukemia is a cancer of the blood in which too many lymphocytes, a type of white blood cell, are produced by the bone marrow and organs of the lymphatic system. Normally, most lymphocytes fight infection by making antibodies that attack harmful elements. However, with chronic lymphocytic leukemia, the cells are immature and overabundant. They crowd out other blood cells, and may collect in the blood, bone marrow, and lymph tissue.
Early in the disease, there may be no noticeable symptoms, and many cases are diagnosed on routine blood tests. The following are the most common symptoms of chronic lymphocytic leukemia. However, each individual may experience symptoms differently. Symptoms may include:
- Persistent weakness or fatigue
- Swollen lymph nodes
- Enlarged spleen, which can cause loss of appetite
- Enlarged liver
- Night sweats
- Weight loss
- Frequent infections
- Easy bruising or bleeding