FDA approves new use for Celgene’s cancer drug Revlimid

By Toni Clarke WASHINGTON (Reuters) – The U.S. Food and Drug Administration has expanded the authorized use of Celgene Corp’s cancer drug Revlimid to include newly diagnosed patients with multiple myeloma, the company said on Wednesday. Physicians in the United States have long been prescribing Revlimid for new patients on an “off-label” basis, but the company had not been allowed to promote its use in this population. The FDA’s action means Celgene can market Revlimid, in combination with a different drug, dexamethasone, as a treatment for all multiple myeloma patients and helps validate the company’s premise that treating patients earlier and for a longer period of time increases progression-free survival. The approval is expected to only modestly increase sales in the United States since doctors are already prescribing the drug for newly diagnosed patients.
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