Celgene announces regulatory submissions for blood cancer therapies REVLIMID and ISTODAX

Jan 5 2011

Celgene International Sàrl (NASDAQ: CELG) announced regulatory submissions for its blood cancer therapies REVLIMID (lenalidomide) and ISTODAX (romidepsin).

The company submitted a Marketing Authorisation Application (MAA) for the approval of REVLIMID (lenalidomide) 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 with the European Medicines Agency (EMA) on December 31, 2010.

The MAA will be reviewed by the Committee for Medicinal Products for Human Use (CHMP). Review of each application will be conducted by the EMA under the centralised licensing procedure, which, when finalised, provides one marketing authorisation in all 27 member states of the European Union.

The application was based on the results of MM-015, an international, randomised 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.

In addition to the European submission for REVLIMID, a Supplemental New Drug Application (sNDA) was submitted to the U.S. Food and Drug Administration (FDA) on December 17, 2010 for ISTODAX in the treatment of patients with peripheral t-cell lymphoma (PTCL) who have received at least one prior therapy. The sNDA submission was based on a pivotal, phase II, multicenter, international, open-label study of romidepsin in patients with progressive or relapsed PTCL following prior systemic therapy.

The sNDA will now be reviewed for acceptance under current FDA guidelines.