Celgene applies for EU approval of Revlimid

Celgene has applied to the European Medicines Agency (EMA) for approval of its blood cancer therapy Revlimid.

A marketing authorisation application has been submitted for the drug as a maintenance treatment among multiple myeloma patients who have failed to progress following initial exposure to specified therapies.

The application has been submitted on the basis of positive clinical data from the recent MM-015 phase III study, as well as results from two additional placebo-controlled phase III trials.

Revlimid's safety and efficacy profile will now be reviewed by the EMA's Committee for Medicinal Products for Human Use, before being assessed under the regulator's centralised licensing procedure.

If approved, Celgene will be able to make the treatment available for sale in all 27 EU member states.

Last month, the manufacturer published data from two phase II clinical studies which demonstrated the potential effectiveness of Revlimid as part of a combination treatment option for indolent non-Hodgkin's lymphoma.