- The FDA has approved Celgene's Revlimid (lenalidomide) for use in newly diagnosed patients with multiple myeloma, in combination with dexamethasone. This means that it is now approved for all patients with multiple myeloma.
- Revlimid is approved in the U.S. for the treatment of mantle cell lymphoma patients whose disease has progressed after two prior therapies, and also myelodysplastic syndromes.
- Many physicians in the U.S. have already been prescribing Revlimid off-label for new multiple myeloma patients. But what has Celgene really excited about the news is that it foretells a cascade of new approvals throughout the world that will greatly boost Revlimid sales.
Generally, an expanded label means more revenues. But in the U.S., physicians have been using Revlimid off-label for some time.
The situation is different in Europe, where physicians are not allowed to prescribe drugs off-label. Celgene is reportedly anticipating an approval of Revlimid for newly diagnosed multiple myeloma patients within a matter of weeks, and this could result in a substantial increase in revenues outside of the U.S.
Based on 2014 figures, Revlimid generated $2.92 billion in the U.S. and $2.06 billion in the rest of the world, which in this case is 70 countries in which the drug is approved for patients who have received at least one other therapy. With an E.U. approval, there is a strong possibility that other regulatory markets will start approving Revlimid for newly diagnosed patients, which will in turn have a significant impact on sales. Analysts predict that it could amount to as much as $10 billion in the next five years.
Celgene's stock is trading near its all-time high.