Acalabrutinib receives FDA go-ahead for mantle cell lymphoma
medwireNews: The kinase inhibitor acalabrutinib has been approved by the US Food and Drug Administration for the treatment of adults with mantle cell lymphoma who have received at least one prior treatment.
The oral agent, which is targeted for patients with monoclonal B cells that have the t(11;14)(q13;q32) translocation and/or overexpress cyclin D1, is recommended at a 100 mg twice daily dose.
Acalabrutinib received accelerated approval, as well as orphan drug and breakthrough therapy status, following results from the open-label ACE-LY-004 study of 124 patients with refractory mantle cell lymphoma; the overall response rate was 81% and the complete response rate 40%, with the median duration not yet determined after 15 months.
Common adverse reactions to acalabrutinib include anemia, thrombocytopenia, headache, and neutropenia.
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