Celgene makes regulatory submissions for Revlimid and Istodax

Celgene International Sarl, a Swiss unit of USA-based Celgene Corp (Nasdaq: CELG) has announced regulatory submissions for its blood cancer therapies Revlimid (lenalidomide) in Europe and Istodax (romidepsin) in the USA.

The company submitted a Marketing Authorization Application (MAA) for the approval of Revlimid for maintenance treatment of newly-diagnosed multiple myeloma patients who have not progressed following initial treatment with melphalan, prednisone and Revlimid, or following autologous stem cell transplantation. The application was submitted to the European Medicines Agency (EMA) on December 31, 2010.

The application was based on the results of MM-015, an international, randomized pivotal Phase III study. The submission is also supported by two additional Phase III studies comparing continuous Revlimid therapy following autologous stem cell transplant versus placebo. Unprecedented results from these Phase III studies were presented at the American Society of Hematology Annual Meeting in December 2010, the company noted.