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WASHINGTON -- The FDA granted accelerated approval to the Bruton's tyrosine kinase (BTK) inhibitor acalabrutinib (Calquence) for relapsed/refractory mantle cell lymphoma (MCL).

The approval makes the drug available for patients with MCL that did not respond or relapsed after at least one prior line of therapy. The accelerated approval status comes with the stipulation that initial favorable results with the agent will be confirmed or corroborated in more definitive clinical studies.

"Mantle cell lymphoma is a particularly aggressive cancer," Richard Pazdur, MD, of the FDA Office of Hematology and Oncology Products, said in a statement. "For patients who have not responded to treatment or who have relapsed, Calquence provides a new treatment option that has shown high rates of response for some patients in initial studies."

Support for accelerated approval came from a single-arm trial involving 124 patients who had received at least one prior regimen for MCL. The trial had a primary endpoint of objective response, and the results showed an overall response rate of 81% with acalabrutinib: 40% complete response and 41% partial response.

Side effects commonly associated with acalabrutinib included headache, diarrhea, bruising, fatigue, myalgia, anemia, thrombocytopenia, and neutropenia. Serious side effects associated with the drug included hemorrhage, infections, and atrial fibrillation. Additionally, some patients developed second primary malignancies while taking acalabrutinib.

The FDA granted the conditional approval to AstraZeneca.

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