US FDA expands use of Celgene’s Revlimid

US biotech firm Celgene (Nasdaq: CELG) revealed that the US Food and Drug Administration has expanded the existing indication for Revlimid (lenalidomide) in combination with dexamethasone to include patients newly-diagnosed with multiple myeloma (NDMM).

Revlimid plus dexamethasone was previously approved in June 2006 for use in multiple myeloma patients who have received at least one prior therapy. Full-year 2014 sales of Revlimid, Celgene’s leading drug, grew 156% to $4.98 billion

“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,” said Kenneth Anderson, director, Jerome Lipper Multiple Myeloma Center, Dana-Farber/Brigham and Women’s Cancer Center, adding: “We now have clinical evidence demonstrating that starting and keeping newly diagnosed multiple myeloma patients on Revlimid significantly improves progression-free survival.”