AbbVie announced the European Commission granted marketing authorization for IMBRUVICA® (ibrutinib) as the first treatment option available in all 28 member states of the European Union (EU) for the treatment of Waldenstrom's macroglobulinemia (WM), a rare, slow growing blood cancer, in adult patients who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy. Pharmacyclics LLC, an AbbVie company, received FDA approval for IMBRUVICA, which is also the first and only FDA-approved treatment for WM in the United States, in January 2015. The approval of IMBRUVICA to treat patients with WM triggers a $20 million milestone payment from Janssen.
IMBRUVICA is jointly developed and commercialized in the United States by Pharmacyclics and Janssen Biotech, Inc. In Europe, Janssen-Cilag International NV (Janssen) holds the marketing authorization and its affiliates market IMBRUVICA in EMEA (Europe, Middle East, Africa), as well as the rest of the world. IMBRUVICA is already approved in Europe to treat adult patients with relapsed or refractory mantle cell lymphoma (MCL) and adult patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy or in first line use in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy.
WM (a clinically recognized subset of lymphoplasmacytic lymphoma, or LPL) is a slow-growing and rare blood cancer that most commonly originates from B cells, a type of white blood cell (lymphocyte) that develops in the bone marrow. WM occurs as the result of a malfunction in the healthy lifecycle of a B cell, causing the cell to become malignant and reproduce at an abnormal rate. The malignant B cells produce large amounts of an abnormal type of antibody protein called immunoglobulin M (IgM). Excess IgM causes the blood to thicken and causes many of the symptoms of WM.
