Janssen and Pharmacyclics submit EMA application to expand indication for Imbruvica

US health care giant Johnson & Johnson’s (NYSE: JNJ) Belgium-based subsidiary Janssen-Cilag International has submitted a Type II variation application to the European Medicines Agency to vary the marketing authorization for Imbruvica (ibrutinib), to include a new therapeutic indication for the treatment of adult patients with Waldenström’s macroglobulinemia (WM).

WM is a rare type of B-cell lymphoma. If approved, this latest regulatory submission will expand the indications for Imbruvica to a third type of blood cancer. Imbruvica is a first-in-class, once-daily, oral Bruton’s tyrosine kinase (BTK) inhibitor.

Thomas Stark, Vice President Medical Affairs, Janssen EMEA, said: “At Janssen, we strive to develop innovative products that prolong and improve patients’ lives. 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.”