Celgene receives CHMP backing for new Revlimid indication

Celgene's oncology agent Revlimid has received a recommendation from Europe's Committee for Medicinal Products for Human Use (CHMP) for approval in a new indication.

The European Medicines Agency committee has adopted a positive opinion on the drug's use among patients with transfusion-dependent anaemia caused by low or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality.

This is a rare form of blood cancer associated with poor prognoses, against which Revlimid has shown strong levels of efficacy in the phase III clinical trial MDS-004.

A final ruling from the European Commission – which typically follows the recommendations of the CHMP – is expected to be issued in the next two to three months.

Alan Colowick, European president of Celgene, said: "Following the final decision by the European Commission within the next few months, we can begin the work of partnering with our many stakeholders to ensure patients have access to this new treatment option."

Last month, the firm announced positive data from a phase III study called Esteem 1, which evaluated the efficacy of a new apremilast-based therapy for psoriasis.