Imbruvica Approval Expanded to Include Chronic Leukemia
WEDNESDAY Feb. 12, 2014, 2014 -- 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 other anti-cancer therapy.
CLL progresses slowly, gradually leading to an increase in white blood cells called B lymphocytes. 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: low blood platelets, diarrhea, bruising, upper respiratory tract infection, fatigue and muscle pain.
Imbruvica is manufactured by Pharmacyclics, based in Sunnyvale, Calif.
The FDA has more about this approval.
Posted: February 2014
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