FDA Approves Imbruvica For Mantle Cell Lymphoma

The Food and Drug Administration Nov. 13 approved Imbruvica (ibrutinib) to treat patients with mantle cell lymphoma (MCL), a rare and aggressive type of blood cancer.

Imbruvica is the second drug with breakthrough therapy designation to receive the FDA’s approval, the agency said.

MCL is a rare form of non-Hodgkin lymphoma and represents about 6 percent of all non-Hodgkin lymphoma cases in the U.S., the agency said. By the time MCL is diagnosed, it usually already has spread to the lymph nodes, bone marrow and other organs.

Imbruvica is intended for patients with MCL who have received at least one ...