Imbruvica Approved for Mantle Cell Lymphoma
WEDNESDAY, Nov. 13 -- Imbruvica (ibrutinib) has been approved by the U.S. Food and Drug Administration to treat mantle cell lymphoma (MCL), a rare but aggressive form of blood cancer.
MCL represents about six percent of non-Hodgkin lymphoma cases, the agency said Wednesday in a news release. By the time it's usually diagnosed, it has spread to other areas such as the lymph nodes or bone marow.
Imbruvica, designed to inhibit an enzyme that cancer cells need to spread, was granted the FDA's rare "breakthrough therapy" status as a drug that promises to offer a "substantial improvement over available therapies for patients with serious or life-threatening diseases," the agency said.
Imbruvica was evaluated in a study of 111 participants. Of those who took the drug daily, 66 percent had their cancer shrink or disappear, the FDA said. The most common side effects included: low blood platelets, diarrhea, low white blood cells, anemia, fatigue, musculoskeletal pain, swelling and upper respiratory infection.
Imbruvica is co-marketed by Sunnyvale, Calif.-based Pharmacyclics, and Raritan, N.J.-based Janssen Biotech.
To learn more about non-Hodgkin lymphoma, visit Medline Plus.
Posted: November 2013