FDA: ibrutinib approval to include CLL
FDA Expands Imbruvica Approval to Include CLL
(HealthDay News) -- U.S. Food and Drug Administration approval of Imbruvica (ibrutinib) has been expanded to include people with chronic lymphocytic leukemia (CLL) who have tried at least one previous therapy.
Last year, some 15,680 Americans were diagnosed with CLL and 4,580 died from it, the agency said Wednesday in a news release, citing the National Cancer Institute.
Imbruvica was approved last November to treat people with mantle cell lymphoma.
Approval for CLL was based on clinical studies involving 48 people, the FDA said. Some 58 percent of participants had their cancer shrink after treatment.
Among the most common side effects of the drug were thrombocytopenia, diarrhea, bruising, upper respiratory tract infection, fatigue, and musculoskeletal pain.
Imbruvica is manufactured by Pharmacyclics, based in Sunnyvale, Calif.