Celgene Corp said on Wednesday that its flagship blood cancer drug, Revlimid, was approved by U.S. health regulators to treat mantle cell lymphoma, adding another revenue source for the $4 billion-a-year medicine.
The U.S. Food and Drug Administration approved Revlimid to treat mantle cell lymphoma (MCL) - a type of non-Hodgkin's lymphoma - that has relapsed or progressed following two prior treatment regimens, one of which must include Takeda Pharmaceutical Co's Velcade.
"There remains a tremendous unmet need for patients with previously treated mantle cell lymphoma," Dr Andre Goy, chairman and director and chief of lymphoma at the John Theurer Cancer Center in Hackensack, New Jersey, said in a statement.
Revlimid, which will be the first oral treatment for MCL, is already approved to treat multiple myeloma and the blood disorder myelodysplastic syndromes.
The medicine had sales of $1 billion in the first quarter for the U.S. biotechnology company.
Despite the unmet need cited by doctors, analysts predicted only a modest revenue boost for Revlimid from the new indication. Cowen and Co analyst Eric Schmidt forecast additional annual sales of about $100 million to $200 million from the additional approval, saying it was not likely to provide a boost to Celgene's shares.
MCL accounts for about 6 percent to 7 percent of total non-Hodgkin's lymphoma cases, or about 11,000 cases, the company said.
Celgene shares were off 3.4 percent at $113.69 in afternoon trading on Nasdaq on a down day for biotechs and the broader market.
(Reporting by Bill Berkrot in New York; editing by Matthew Lewis and Kenneth Barry)