Janssen files for EU approval of new blood cancer therapy

Janssen has applied for European regulatory approval of the new compound ibrutinib for the treatment of adult patients with two forms of blood cancer.

The marketing authorisation application submitted to the European Medicines Agency is seeking approval of the drug as a means of treating relapsed/refractory chronic lymphocytic leukaemia (CLL)/small lymphocytic leukaemia (SLL), or relapsed/refractory mantle cell lymphoma (MCL).

A similar application has already been submitted to the US Food and Drug Administration based on the strong performance of the therapy in clinical trials.

Ibrutinib is administered orally and is the first in a class of medicines called Bruton's tyrosine kinase inhibitors, which has been developed collaboratively by Janssen and Pharmacyclics.

Jane Griffiths, group company chairman of Janssen in Europe, the Middle East and Africa, said: "If approved, ibrutinib will address a great unmet need for patients with CLL/SLL and MCL who have previously failed or become resistant to previous treatment."

This comes after the manufacturer also submitted a European marketing authorisation application for a darunavir-containing therapy option for HIV last month.