FDA Expands Approved Use of Leukemia Drug Imbruvica

Based on positive results from the RESONATE clinical trial, the U.S. Food and Drug Administration has approved Imbruvica (ibrutinib) for treatment in chronic lymphocytic leukemia (CLL) patients who carry a deletion in chromosome 17. Patients with this deletion typically respond poorly to standard treatment for CLL, which is a cancer of the blood and bone marrow.

New clinical data on patients’ overall survival and progression-free survival also prompted the FDA to approve a labeling change showing that it has verified Imbruvica’s clinical benefit in treating CLL. Approximately 15,720 new cases of CLL will be diagnosed this year, and 4,600 deaths will result from it, according to the National Cancer Institute.

“We continue to see advances in the availability of therapies to treat chronic lymphocytic leukemia, especially for difficult-to-treat patient populations,” says Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA Center for Drug Evaluation and Research.

Meanwhile, studies are taking place to verify Imbruvica’s benefit for mantle cell lymphoma patients who have had at least one prior therapy. The drug was granted accelerated approval for this use last November.