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Acalabrutinib receives accelerated approval for mantle cell lymphoma
The FDA today granted accelerated approval to acalabrutinib for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy.
Acalabrutinib (Calquence, AstraZeneca) is a kinase inhibitor that works by blocking an enzyme needed by the cancer to multiply and spread.
“Mantle cell lymphoma is a particularly aggressive cancer,” Richard Pazdur, MD, 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, said in a press release. “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.”
The agency’s decision is based on data from a single-arm study, designed to evaluate acalabrutinib in 124 patients with mantle cell lymphoma who had received at least one prior treatment.
Overall response rate served as the primary endpoint.
Eighty-one percent of patients achieved a complete or partial response, including 40% with a complete response and 41% with partial responses.
Common side effects included headache; diarrhea; bruising; fatigue; muscle pain; and reduced levels of red blood cells, platelets and neutrophils in the blood.
Serious adverse events included hemorrhage, infections and atrial fibrillation.