FDA granted accelerated approval to ibrutinib(IMBRUVICA)

摘要

On Feb.12,2014,the U.S.Food and Drug Administration granted accelerated approval to ibrutinib(IMBRUVICA,Pharmacyclics,Inc.)for the treatment of patients with chronic lymphocytic leukemia(CLL)who have received at least one prior therapy.Ibrutinib previously received accelerated approval on November 13,2013 for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy.The approval in CLL was based on the results of a multicenter,singlearm trial of 48 patients with previously treated CLL.The median age was 67 years(range,37 to 82 years)and 71%were male.All patients had a baseline ECOG performance status of 0 or 1.The median time since diagnosis was 6.7 years and the median number of prior treatments was 4(range,1 to 12 treatments).Ibrutinib was administered orally at 420 mg once daily until disease progression or unacceptable toxicity.