Celgene slumps as it pulls new EU indication filing for Revlimid

Celgene International, the European subsidiary of USA-based Celgene Corp (Nasdaq: CELG), has provided a regulatory update for Revlimid (lenalidomide) and pomalidomide as treatments for multiple myeloma, saying that it has decided to withdraw the new indication submission to the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

The new indication was intended for the maintenance treatment of newly diagnosed multiple myeloma patients who have not progressed following initial treatment with melphalan, prednisone and Revlimid or maintenance therapy following autologous stem cell transplantation. The news pushed Celgene’s stock 12% lower to $59.15 in early trading yesterday. Revlimid is Celgene’s best-selling drug, generating sales of $3.21 billion last year.

Revlimid was first authorized in the European Union in June 2007 and it is currently indicated in combination with dexamethasone for the treatment of multiple myeloma patients who have received at least one prior therapy. Revlimid continues to be authorized in the currently approved indication.