publication date: Jul. 17, 2015

European Commission Approves Imbruvica In Waldenstrom’s Macroglobulinemia


The European Commission approved Imbruvica capsules (ibrutinib) for adult patients with Waldenstrom’s macroglobulinemia who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.

Imbruvica is co-developed by Cilag GmbH International, a member of the Janssen Pharmaceutical Companies, and Pharmacyclics LLC, an AbbVie company. Janssen affiliates market ibrutinib in Europe, the Middle East and Africa, as well as the rest of the world, except for the U.S., where it is co-marketed by Janssen Biotech Inc. and Pharmacyclics.

Imbruvica has already been approved in Europe for the treatment of adult patients with relapsed or refractory mantle cell lymphoma, or 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. Imbruvica has also been recently approved for the treatment of WM by the U.S. FDA, which granted it Breakthrough Therapy Designation in 2013.

Genome sequencing of patients with WM has revealed a common mutation in the MYD88 gene. This mutation triggers the activation of a number of targets, including Bruton’s tyrosine kinase, which is a key component needed to regulate immune cell proliferation and cell survival which plays a part in B-cell malignancies, such as WM. Imbruvica forms a strong covalent bond with BTK, thereby inhibiting the enzyme and blocking the transmission of cell survival signals within the malignant B cells.

The phase II multi-center study on which the approval was based evaluated the efficacy and tolerability of Imbruvica … Continue reading 41-28 EU Approves Imbruvica In WM

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