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news.Janssen-Cilag International (Janssen) has submitted a Type II variation application to the European Medicines Agency (EMA) to include a new therapeutic indication for Imbruvica (ibrutinib), to treat adults with Waldenström's macroglobulinemia (WM).
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If approved, the latest regulatory submission will expand the indications for Imbruvica to a third type of blood cancer.
Cilag, a Janssen Pharmaceutical member, and Pharmacyclics Switzerland are jointly developing Imbruvica, a first-in-class, once-daily, oral Bruton’s tyrosine kinase (BTK) inhibitor.
Imbruvica is marketed in Europe, Middle East and Africa (EMEA) as well as the rest of the world by Janssen affiliates, while in the US the two companies co-market the drug.
Janssen EMEA vice-president Medical Affairs Thomas Stark said: "This additional application for IMBRUVICA, for the treatment of Waldenström’s macroglobulinemia, is an important milestone for patients suffering from the disease who currently have limited treatment options in Europe.
"If approved, IMBRUVICA has the potential to address a high unmet need among patients with this difficult to treat blood cancer."
WM is a slow-growing blood cancer that originates from B cells, a type of white blood cell (lymphocyte) that develops in the bone marrow.
In October 2014, Imbruvica secured approval from the European Commission to treat adults with relapsed or refractory mantle cell lymphoma (MCL), and adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.