Imbruvica filed with EU for Waldenström's Macroglobulinemia- Janssen
Janssen-Cilag announced the submission of a Type II variation application to the European Medicines Agency (EMA) to vary the marketing authorisation for Imbruvica (ibrutinib), to include a new therapeutic indication, the treatment of adult patients with Waldenström's Macroglobulinemia. Imbruvica received European Commission approval in October 2014 for the treatment of adult patients with relapsed or refractory Mantle Cell Lymphoma, and for adult patients with Chronic Lymphocytic Leukaemia 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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