US FDA backs new indication for Celgene's Revlimid

The US Food and Drug Administration has approved US biotech firm Celgene’s (Nasdaq: CELG) supplemental New Drug Application for Revlimid (lenalidomide) for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.

“There remains a tremendous unmet need for patients with previously-treated mantle cell lymphoma,” said Andre Goy, chairman and director and chief of the Lymphoma, John Theurer Cancer Center at Hackensack UMC and chief science officer and director of research and innovation at Regional Cancer Care Associates, adding: “The approval of lenalidomide delivers a new option, and the first oral therapy in this area of lymphoma.”

Revlimid, which is the first oral drug cleared for MCL, was approved in the USA in 2005, as well as subsequently in more than 70 countries, for the treatment of multiple myeloma and is also cleared in some countries for the treatment of transfusion-dependent anemia due to low- or intermediate-1-risk MDS associated with a deletion 5q cytogenetic abnormality. The drug generated sales of $3.8 billion in2012 and revenues are expected to reach $5.9 billion in 2016, according to 14 analysts’ estimates compiled by Bloomberg. The new indication fior Revlimid, by far Celgene’s biggest earner with first-quarter 2013 sales topping $1 billion, is expected to add around $100-$200 million to that figure.