EMA Advisory Committee Recommends Janssen’s Cancer Drug Imbruvica for ApprovalBy
Janssen-Cilag International NV, part of Johnson & Johnson, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommending the marketing authorization for Imbruvica (ibrutinib), a drug to treat relapsed or refractory mantle cell lymphoma (MCL), a rare form of B-cell lymphoma as well as for treating chronic lymphocytic leukemia (CLL) in patients 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.
The CHMP is the committee responsible for the scientific assessment of products seeking centralized marketing authorization throughout the European Union. The positive opinion for ibrutinib is now referred for approval to the European Commission, which will decide on whether to follow its guidance and grant authorization for commercialization of ibrutinib.
Ibrutinib is being co-developed by Janssen and Pharmacyclics Switzerland GmbH. Once approved, Janssen will market ibrutinib in EMEA (Europe, Middle East, Africa) as well as the rest of the world, except for the United States, where both companies co-market it. Imbruvica received approval from the US Food and Drug Administration in November 2013 for the treatment of patients with MCL and in February 2014 for the treatment of CLL, in patients who have received at least one prior therapy. It is also approved in Israel for the treatment of adult patients with MCL who have received at least one prior therapy.
Ibrutinib is being studied alone and in combination with other treatments, in several blood cancers including CLL, MCL, Waldenstrom’s macroglobulinemia, diffuse large B-cell lymphoma, follicular lymphoma, and multiple myeloma. Ibrutinib is part of a class of medicines called Bruton's tyrosine kinase (BTK) inhibitors. Studies have shown ibrutinib works by blocking BTK, a protein that helps certain cancer cells live and grow.
Source: Johnson & Johnson