FDA expands approval of Revlimid to include newly diagnosed multiple myeloma

The FDA expanded the approved indication of lenalidomide plus dexamethasone to include patients with newly diagnosed multiple myeloma.

In June 2006, the FDA approved use of lenalidomide (Revlimid, Celgene) in combination with dexamethasone for the treatment of patients with multiple myeloma who had received at least one prior therapy.

"The approval of Revlimid as an option for use in all patients with multiple myeloma represents a new paradigm in the management of this disease," Kenneth C. Anderson, MD, director of the Jerome Lipper Multiple Myeloma Center at Dana-Farber/ Brigham and Women's Cancer Center, said in a press release. "We now have clinical evidence demonstrating that starting and keeping newly diagnosed multiple myeloma patients on Revlimid significantly improves progression-free survival."

The FDA based its decision to expand the approval of lenalidomide on results of multiple phase 3 studies, including the FIRST trial.

In the primary analysis of the...