Janssen-Cilag International NV (Janssen) has announced that the European Commission has approved ibrutinib (imbruvica™) 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.

Ibrutinib 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.

In the European Economic Area, Janssen is the marketing authorisation holder.

Janssen affiliates market Imbruvica (ibrutinib) 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.

This approval allows for the marketing of Imbruvica (ibrutinib) in all 28 countries of the European Union.

“MCL and CLL with 17p deletion are usually challenging and difficult-to-treat blood cancers that do not respond well to conventional therapies. They usually rapidly progress during or soon after chemotherapy leaving patients with very limited treatment options and poor survival,” said Professor Peter Hillmen, Haematology, St. James’s University Hospital, Leeds, who is an investigator in the ibrutinib CLL clinical trial.

CLL in most patients is a slow-growing blood cancer, starting from white blood cells (called lymphocytes) in the bone marrow.

The chromosomal abnormalities deletion 17p (del17p) and TP53 mutation are associated with aggressive, treatment-resistant disease.

 MCL is a rare and aggressive type of B-cell lymphoma that can be challenging to treat and is associated with a poor prognosis.

The approval of ibrutinib was based on data from the Phase 3 (RESONATE™ PCYC-1112) and Phase 1b-2 (PCYC-1102) studies in CLL, and the Phase 2 study (PCYC-1104) in MCL. 

Source: Janssen