Revlimid Earns EC Approval and FDA-Expanded Indication for Multiple Myeloma Following Stem Cell Transplant

Celgene’s Revlimid has won European Commission and FDA approvals as a maintenance treatment of adult patients with newly diagnosed multiple myeloma that have undergone autologous stem cell transplantations.

The decision to approve Revlimid as monotherapy in that setting was based on the results of two cooperative group-led studies, CALGB 1001049 and IFM 2005-02.

Revlimid, in combination with dexamethasone, was previously approved in June 2006 for use in patients with multiple myeloma that have received at least one prior therapy, and the indication was expanded by the FDA in February 2015 to include patients recently diagnosed with multiple myeloma.