Calquence Approved for Mantle Cell Lymphoma
TUESDAY, Oct. 31, 2017 -- Calquence (acalabrutinib) has been approved by the U.S. Food and Drug Administration to treat adults with mantle cell lymphoma.
Calquence is a Bruton tyrosine kinase (BTK) inhibitor. The drug was evaluated in a clinical study of 124 people with mantle cell lymphoma who had received at least one prior treatment. Some 81 percent of trial participants given the drug had a complete or partial response.
Common adverse effects include headache, diarrhea, bruising, myalgia, anemia, thrombocytopenia and neutropenia. Serious adverse reactions include hemorrhage, infections, atrial fibrillation, and second primary malignancies, the FDA said.
"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," Richard Pazdur, M.D., director of the FDA's Oncology Center of Excellence, said in a statement.
The FDA granted accelerated approval of Calquence to AstraZeneca, based in the United Kingdom.
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Posted: October 2017