Imbruvica gets expanded approval from FDA

SILVER SPRING, Md. — The Food and Drug Administration on Monday expanded the approved use of Imbruvica (ibrutinib) to treat patients with chronic lymphocytic leukemia who carry a deletion in chromosome 17, which is associated with poor responses to the standard treatment for CLL, according to the agency. The drug received breakthrough therapy designation for this use.



The agency is also approving new labeling to reflect the drug's clinical benefit in treating CLL, which is a rare blood and bone marrow disease that typically gets worse slowly over time. This causes a gradual increase in white blood cells called B lymphocytes.



“We continue to see advances in the availability of therapies to treat chronic lymphocytic leukemia, especially for difficult-to-treat patient populations,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Imbruvica is the fourth drug approved to treat CLL that received a breakthrough therapy designation, reflecting the promise of the breakthrough therapy designation program and demonstrating the FDA’s commitment to working cooperatively with companies to expedite the development, review and approval of these important new drugs.”

Imbruvica is co-marketed by Pharmacyclics and Janssen Biotech.