Janssen receives CHMP backing for EU approval of new Imbruvica indication

Janssen has announced that its cancer drug Imbruvica has been recommended for European approval in a new indication.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has backed the use of the drug as a single agent for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia.

Data from the phase III RESONATE-2 trial showed Imbruvica provided a significant improvement in all efficacy endpoints versus chlorambucil in patients aged 65 or older who were newly diagnosed with the disease.

A final decision from the European Commission is now expected within the next few months.

Jane Griffiths, chairman of Janssen's Europe, Middle East and Africa, said: "Ibrutinib continues to demonstrate impressive clinical results, and the data on which this recommendation is based once again highlight its potential to deliver improved patient outcomes for suitable patients."

Currently, the drug is available only to chronic lymphocytic leukaemia patients who have received at least one prior therapy or who have genetic mutations typically associated with poor treatment outcomes.