According to a story from PR Newswire, the US Food and Drug Administration (FDA) has recently granted supplemental approval to the drug acalabrutinib (marketed as Calquence) as a treatment for chronic lymphocytic leukemia and small lymphocytic lymphoma. The approval was granted in the context of a special international program called Project Orbis, in which the agency partnered with Australia’s Therapeutic Goods Administration (TGA) and Health Canada.
About Chronic Lymphocytic Leukemia
Chronic lymphocytic leukemia is a form of blood cancer which affects lymphocytes, which are a type of white blood cell. Small cell lymphoma is a very similar disease that differs only by where the cancer cells are found (the lymph nodes instead of the blood/bone marrow). The disease may not cause noticeable symptoms in its early stages. This cancer is linked to certain genetic mutations; notable risk factors for this blood cancer include old age, being male, exposure to certain insecticides, exposure to Agent Orange, and family history. Symptoms of chronic lymphocytic leukemia include fever, anemia, swollen lymph nodes, weight loss, and fatigue. It is also possible for this disease to transform into a more aggressive and faster progressing type of blood cancer like Hodgkin’s lymphoma. Treatment for this disease focuses mostly on controlling symptoms, and there is no cure. These treatments may include radiation therapy, chemotherapy, surgery, bone marrow transplant, or biological therapy. As a slow growing cancer, the five year survival rate is 83 percent. To learn more about chronic lymphocytic leukemia, click here.
About Project Orbis
Project Orbis is a special framework that allows for collaborative review and submission of drugs designed to treat cancer. The project conducts its activities via partnership agreements between the FDA and corresponding regulatory agencies in other countries around the world. The ultimate goal is to allow new treatments for cancer to become available to patients across the globe more quickly and efficiently. The first approval under Project Orbis took place earlier this year in September, for endometrial cancer.
Improving Progression Free Survival
The approval follows the results from two trials that compared Calquence to other treatment options for chronic lymphocytic leukemia. The first trial included 535 patients who had yet to receive treatment. Calquence was able to provide a longer period of progression free survival when compared to other methods. The second study included 310 patients that had previously been treated. In this study, Calquence was again able to provide a longer period of progression free survival.
