The U.S. Food and Drug Administration has granted accelerated approval to Calquence (acalabrutinib) for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy. Mantle cell lymphoma is a particularly aggressive cancer and new treatments are needed for patients who have not responded to treatment or have relapsed,
Mantle cell lymphoma is a rare and fast-growing type of non-Hodgkin lymphoma and, according to the National Cancer Institute at the National Institutes of Health, represents 3 to 10 percent of all non-Hodgkin lymphoma cases in the U.S. Mantle cell lymphoma is a cancer of the lymph system, which is part of the body’s immune system and is made up of lymph tissue, lymph nodes, the spleen, thymus, tonsils and bone marrow. By the time mantle cell lymphoma is diagnosed, it usually has spread to the lymph nodes, bone marrow and other organs.
Calquence is a kinase inhibitor that works by blocking an enzyme needed by the cancer to multiply and spread. The approval of Calquence was based on the results from a single clinical trial that included 124 patients with mantle cell lymphoma who had received at least one prior treatment. The trial measured how many patients experienced a complete or partial shrinkage of their tumors after treatment. Overall, 81 percent of patients had a complete or partial response (40 percent complete response, 41 percent partial response).
Common reported side effects of Calquence included headache; diarrhea; bruising; fatigue and muscle pain (myalgia); and reduced levels of red blood cells (anemia), platelets (thrombocytopenia) and neutrophils (neutropenia) in the blood. Additional cancers, known as second primary malignancies, have occurred in some patients taking Calquence, and women who are breastfeeding should not take Calquence because it may cause harm to a newborn baby.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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