Celgene, the company that markets Revlimid in the United States and internationally, announced this morning that it has withdrawn its application in Europe to have the drug approved for use as initi
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Celgene, the company that markets Revlimid in the United States and internationally, announced this morning that it has withdrawn its application in Europe to have the drug approved for use as initial therapy for newly diagnosed myeloma patients as well as for maintenance therapy.
The company also is postponing until next year a similar application it had intended to file in 2012 with the U.S. Food and Drug Administration (FDA).
The European application was withdrawn due to concerns raised by regulators about the link between Revlimid (lenalidomide) and second cancers (also known as second primary malignancies).
Celgene’s announcement came as a surprise to many observers — so much so that Celgene’s stock declined more than 11 percent today.
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