FDA Approves Acalabrutinib (Calquence) for Mantle Cell Lymphoma

Nick Mulcahy


October 31, 2017

The US Food and Drug Administration (FDA) granted an accelerated approval today to acalabrutinib (Calquence, AstraZeneca) for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy.

"For patients who have not responded to treatment or have relapsed, acalabrutinib provides a new treatment option that has shown high rates of response for some patients in initial studies," said 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.

Acalabrutinib is a second-generation Bruton's tyrosine kinase (BTK) inhibitor that is described as being more selective in targeting alternative kinases than first-generation products such as ibrutinib (Imbruvica, Pharmacyclics and Janssen).

The new approval of acalabrutinib is based on results from a single-arm trial that included 124 patients with mantle cell lymphoma who had received at least one prior treatment. In the trial, the overall response rate was 81% (40% complete responses and 41% partial responses).

Common adverse events of acalabrutinib include headache, diarrhea, bruising, fatigue, and myalgia, as well as anemia, thrombocytopenia, and neutropenia.

Serious side effects include hemorrhage, infections, and atrial fibrillation. Second primary malignancies have occurred in some patients receiving acalabrutinib.

As a drug that has received an accelerated approval, acalabrutinib must be further studied to verify and further establish its clinical benefits; AstraZeneca is currently conducting a trial for that purpose.

Mantle cell lymphoma is a fast-growing type of non-Hodgkin lymphoma. "Mantle cell lymphoma is a particularly aggressive cancer," observed Dr Padzur.

It represents 3% to 10% of all cases of non-Hodgkin lymphoma in the United States, according to the National Cancer Institute of the National Institutes of Health.

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