On October 31, 2017, the FDA accelerated the approval of Calquence (acalabrutinib; from AstraZeneca) for the treatment of adults with mantle-cell lymphoma who have received at least 1 previous therapy. Mantle-cell lymphoma is a rare and fast-growing type of non-Hodgkin lymphoma.
“Mantle cell lymphoma is a particularly aggressive cancer,” said Richard Pazdur, MD, Director of the FDA’s Oncology Center of Excellence. “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.”
This approval was based on a clinical trial of patients with mantle-cell lymphoma that showed that 81% of patients who received Calquence had a complete or partial response to this drug. Serious side effects with Calquence include bleeding, infections, and irregular heartbeat. Women who breastfeed should not take this drug. In addition, new cases of cancer occurred in some patients who used Calquence.