Janssen's Imbruvica Approved by the European Commission

Janssen-Cilag International NV (Janssen) announced today that the European Commission has approved IMBRUVICA™ (ibrutinib) capsules, a first-in-class, once-daily, oral Bruton's tyrosine kinase (BTK) inhibitor. This new approach to treating blood cancers works by blocking BTK, a protein that helps certain cancer cells live and grow.¹ IMBRUVICA is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL), or adult patients with chronic lymphocytic leukaemia (CLL) 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.²

IMBRUVICA is co-developed by Cilag GmbH International (a member of the Janssen Pharmaceutical Companies) and Pharmacyclics Switzerland GmbH. In the European Economic Area, Janssen is the marketing authorisation holder. Janssen affiliates market IMBRUVICA in EMEA (Europe, Middle East and Africa) as well as the rest of the world, except for the United States, where both companies co-market it.

The decision from the European Commission follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on 24 July 2014.² This approval allows for the marketing of IMBRUVICA in all 28 countries of the European Union.

Link to Jansenn's press release: http://bit.ly/1wQiYrj