Pharmacyclics, Inc. (PCYC) said the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion recommending a change to the terms of the marketing authorization for IMBRUVICA (ibrutinib) in the European Union to indicate the treatment of adult patients with Waldenström's macroglobulinemia or WM who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.
WM is a rare, slow growing form of blood cancer. IMBRUVICA is also the first and only FDA-approved treatment for WM in the U.S.. The CHMP recommendation follows the January U.S. Food and Drug Administration full approval of IMBRUVICA to treat all lines of patients with WM.
IMBRUVICA is jointly developed and commercialized in the U.S. by Pharmacyclics and Janssen Biotech, Inc. In Europe, Janssen-Cilag International NV holds the marketing authorization and its affiliates market IMBRUVICA in EMEA, 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 and adult patients with chronic lymphocytic leukemia who have received at least one prior therapy or in first line in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy.
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