Celgene's Revlimid gets new EU use

Celgene’s flagship drug, Revlimid (lenalidomide), has been approved for a new use in Europe, for a rare type of lymphatic cancer.

Already one of the world’s top-selling cancer drugs, Revlimid can now be used in the EU for adults with relapsed or refractory mantle cell lymphoma (MCL).

MCL is a rare sub-type of aggressive non-Hodgkin’s lymphoma, occurring in 3-6% of patients.

This has the poorest long-term survival of all B-cell lymphoma subtypes, with fewer than 50% of patients surviving at five years.

Revlimid was fourth in the list of top-selling cancer drugs last year, with sales of around $5.8 billion.

Sales of the drug are expected to increase to more than $10 billion by 2020, a substantial part of a total sales target for that year of $21 billion.

European approval was based on data from MCL-002, a phase 2, multi-centre, randomised open-label study comparing efficacy and safety of Revlimid with investigator’s choice, in 254 patients who were refractory to their last treatment or had relapsed one to three times.

Revlimid showed a significant improvement in progression-free survival of 8.7 months vs 5.2 months in the control arm.

The most frequently observed adverse reactions in the Revlimid arm were neutropenia, anaemia, diarrhoea, fatigue, constipation, pyrexia, and rash.

Revlimid is already indicated for relapsed/refractory MCL in the US, Switzerland, Turkey, Australia and numerous countries in Latin America.