The U.S. Food and Drug Administration today approved ibrutinib as a single treatment for chronic lymphocytic leukemia patients with relapsed or resistant disease.
MD Anderson physicians have been instrumental in the development of the drug, known commercially as Imbruvica, which achieves higher response rates with milder side effects than established treatments for the disease.
They continue to lead clinical trials, including those for new combinations, and lab studies to better understand how ibrutinib works and how drug resistance develops.
"Ibrutinib has distinguished itself by producing durable responses in patients after other treatments have failed and with little toxicity. The main side effect is mild diarrhea which usually resolves over time," says Susan O'Brien, M.D., professor of Leukemia, who led the phase I trial of the drug.
"This is an exciting time for CLL, with ibrutinib and other drugs in clinical trials providing new approaches that move us away from reliance of chemotherapy combinations," O'Brien says.
Milder than chemotherapy
Combinations of chemotherapy and the antibody rituximab have greatly extended survival for many patients in recent years. The standard-of-care combination known as FCR, developed at MD Anderson, puts about one third of patients in remission for 10 years or longer. Even so, chemotherapy side effects remain hard on patients and raise the risk they may develop second cancers down the line.