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US FDA approves Revlimid for multiple myeloma
by: Reuters Health
Celgene Corp. said on Thursday that U.S. health regulators have approved Revlimid to treat multiple myeloma in patients who have failed to respond to a previous treatment.
Revlimid (lenalidomide), which was already approved to treat myelodysplastic syndromes, got the green light from the U.S. Food and Drug Administration for the new use in combination with dexamethasone.
Last month the company won U.S. approval to market another older drug, Thalomid (thalidomide), to treat patients with newly diagnosed multiple myeloma.
Earlier this month, Celgene presented data at a major cancer meeting demonstrating that Revlimid improved survival in previously treated patients with multiple myeloma by at least a year compared with those receiving chemotherapy plus a placebo.
In that study, about half of the patients in the placebo group had died within two years. By contrast, more than half the patients in the Revlimid group are still alive after three years.
Both Thalomid and Revlimid carry prominent warnings that they may cause birth defects and are only available under restricted distribution programs.
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