The U.S. Food and Drug Administration expanded the approved use of Imbruvica (ibrutinib) for patients with Waldenström’s macroglobulinemia (WM), a rare form of cancer that begins in the body’s immune system. The drug received a breakthrough therapy designation for this use, according to a press release.
According to the National Cancer Institute, approximately 70,800 Americans were diagnosed and 18,990 died from non-Hodgkin lymphomas in 2014. Imbruvica works by blocking the enzyme that allows the abnormal B-cells in WM to grow and divide.
“Today’s approval highlights the importance of development of drugs for supplemental indications,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Continued research has discovered new uses of Imbruvica.”
The FDA initially granted Imbruvica accelerated approval in November 2013 for use in patients with mantle cell lymphoma who received one prior therapy. In February 2014, the FDA granted accelerated approval to Imbruvica for use in patients with previously treated chronic lymphocytic leukemia (CLL), and then in July 2014, expanded its use to include treatment of CLL patients who carry a deletion in chromosome 17.
Imbruvica is co-marketed by Pharmacyclics, based in Sunnyvale, California, and Janssen Biotech, based in Horsham, Pennsylvania.
Read the full release