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FDA approves new treatment for adults with mantle cell lymphoma

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FDA on Tuesday granted accelerated approval to acalabrutinib (Calquence—AstraZeneca) for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy.

FDA on Tuesday granted accelerated approval to acalabrutinib (Calquence—AstraZeneca) 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, MD, director of FDA's Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in 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. Acalabrutinib is a kinase inhibitor that works by blocking an enzyme needed by the cancer to multiply and spread. AstraZeneca's drug was approved using the Accelerated Approval pathway, under which FDA may approve drugs for serious conditions where there is unmet medical need and a drug is shown to have certain effects that are reasonably likely to predict a clinical benefit to patients. Further study is required to verify and describe anticipated clinical benefits of the drug and the sponsor is currently conducting this trial. The approval was based on data from a single-arm trial that included 124 patients with mantle cell lymphoma who had received at least one prior treatment.

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https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm583076.htm

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