The FDA has granted accelerated approval to AstraZeneca’s 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,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “For patients who have not responded to treatment or have relapsed, Calquence provides a new treatment option that has shown high rates of response for some patients in initial studies.”
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, part of the body’s immune system and 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.
Calquence was approved using the Accelerated Approval pathway, under which the FDA may approve drugs for serious conditions where there is unmet medical need and a drug is likely to benefit patients. Further study is required to verify and describe anticipated clinical benefits of Calquence and the sponsor is currently conducting this trial.The FDA granted this application Priority Review and Breakthrough Therapy designations. Calquence also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases. (Source: FDA Website, October 31, 2017)