Janssen has announced that its cancer therapy Imbruvica has been recommended for European approval against two forms of blood cancer.
The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of the drug as a treatment for adult patients with relapsed or refractory mantle cell lymphoma, or chronic lymphocytic leukaemia.
Developed by Janssen and Pharmacyclics Switzerland, the drug works by blocking BTK, a protein that helps certain cancer cells live and grow.
The therapy is intended for patients who have received at least one prior therapy, or in first-line use in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy. The treatment has shown its safety and efficacy in a number of clinical trials.
Jane Griffiths, group chairman for Janssen in Europe, the Middle East and Africa, said: “We’ve been closely collaborating with the CHMP on the Imbruvica submission and are delighted to receive the positive opinion earlier than expected.”
The product has also now been approved by the US Food and Drug Administration for the treatment of chronic lymphocytic leukaemia.