Celgene has been boosted by the news that the US Food and Drug Administration has expanded approval on its multiple myeloma blockbuster Revlimid to include newly-diagnosed patients.
Revlimid (lenalidomide), in combination with dexamethasone, was approved back in June 2006 for use in MM patients who have received at least one prior therapy. The approval was based on Phase III studies, including the FIRST trial which evaluated a continuous Revlimid/Dex combo until disease progression versus melphalan, prednisone and thalidomide in 1,623 newly- diagnosed patients who were not candidates for stem cell transplant.
The expanded approval “represents a new paradigm in the management of this disease,” said Kenneth Anderson of the Jerome Lipper Multiple Myeloma Center at Dana-Farber. “He added that “we now have clinical evidence demonstrating that starting and keeping newly-diagnosed patients on Revlimid significantly improves progression-free survival”.
Celgene is waiting for a similar expanded label in Europe which should come shortly, given that the European Medicines Agency’s Committee for Medicinal Products for Human Use published a positive opinion in December. These new approvals should boost Revlimid’s already-strong sales – fourth-quarter revenues reached $1.32 billion, up 16%.
