Health Information

FDA Approves Imbruvica for Mantle Cell Lymphoma

FDA Approves Imbruvica for Mantle Cell Lymphoma

Drug designed to inhibit enzyme that cancer cells need to spread; granted "breakthrough therapy" status

WEDNESDAY, Nov. 13 (HealthDay News) -- Imbruvica (ibrutinib) has been approved by the U.S. Food and Drug Administration to treat mantle cell lymphoma (MCL).

MCL represents about 6 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 marrow.

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 thrombocytopenia, diarrhea, neutropenia, anemia, fatigue, musculoskeletal pain, edema, and upper respiratory infection.

Imbruvica is co-marketed by Sunnyvale, Calif.-based Pharmacyclics, and Raritan, N.J.-based Janssen Biotech.

More Information (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm374761.htm )