FDA Expands Use of Imbruvica for Form of Leukemia
MONDAY, July 28, 2014 -- Approved use for Imbruvica (ibrutinib) has been expanded to include people with chronic lymphocytic leukemia (CLL) who have a deletion in chromosome 17, the U.S. Food and Drug Administration said Monday in a news release.
People with the 17p deletion are prone to a poor response to standard therapies for CLL, the agency noted.
CLL, a form of non-Hodgkin lymphoma, generally gets worse over time and leads to a gradual increase in white blood cells called B lymphocytes. Almost 16,000 Americans will be diagnosed with CLL and 4,600 will die from it this year, the FDA said, citing projections from the U.S. National Cancer Institute.
The expanded approval followed a clinical study of 391 people, 127 of whom had the 17p deletion. The trial was stopped early after participants treated with Imbruvica showed a 78 percent reduction in risk of disease progression or death, the FDA said.
The most common side effects reported were a decrease in infection-fighting white blood cells, diarrhea, anemia, fatigue, muscle and bone pain, upper respiratory tract infection, rash, nausea and fever.
Imbruvica was approved in November 2013 to treat mantle cell lymphoma among people who had been given at least one prior therapy.
The drug is co-marketed by Sunnyvale, Calif.-based Pharmacyclics and Horsham, Penn.-based Janssen Biotech.
The FDA has more about this approval.
Posted: July 2014