AbbVie’s Imbruvica approved for chronic lymphocytic leukaemia in Europe

AbbVie has announced that its cancer therapy Imbruvica has been approved in a new indication by the European Commission.

The drug is to be made available as a first-line treatment option for adult patients with chronic lymphocytic leukaemia (CLL), meaning it is now indicated across all lines of CLL in the EU.

This approval is based on positive data from the phase III RESONATE-2 study, which showed that the drug is associated with significant improvements in progression-free and overall survival rates compared to an established therapy.

It means patients with treatment-naive CLL, relapsed/refractory CLL and those with the genetic mutations del 17p or TP53 can all now benefit from treatment with single-agent Imbruvica.

The drug was jointly developed and commercialised in the US by Pharmacyclics and by Janssen Biotech in Europe. Janssen holds the marketing rights in the EU and will be responsible for marketing it through its affiliates.

Imbruvica is also available in Europe as a treatment for Waldenstrom's macroglobulinemia.