On October 31, 2017, the FDA granted accelerated approval to acalabrutinib (Calquence; AstraZeneca) for the treatment of adults with mantle-cell lymphoma (MCL) who have received at least 1 previous therapy. The FDA granted acalabrutinib priority review and breakthrough therapy and orphan drug designations for this indication.
“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.” MCL is a rare and fast-growing type of non-Hodgkin lymphoma.
The safety and efficacy of acalabrutinib were evaluated in Study LY-004, an open-label, phase 2 study involving 124 patients with MCL who received ≥1 previous therapies. Acalabrutinib 100 mg was administered twice daily until disease progression or until unacceptable toxicity. The primary efficacy end point was overall response rate (ORR), and the median follow-up was 15.2 months. The investigator-assessed ORR was 81% (95% confidence interval, 73%-87%), and the median duration of response was not yet reached.
The most common adverse reactions reported with acalabrutinib include anemia, thrombocytopenia, headache, neutropenia, diarrhea, fatigue, myalgia, and bruising.
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