Europe advisory committee supports expanded label for Revlimid
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion supporting the approval of Celgene’s (NASDAQ:CELG) Revlimid (lenalidomide) for the continuous oral treatment on adult patients with previously untreated multiple myeloma who are not eligible for stem cell transplantation.
In the EU, Revlimid is currently approved in combination with dexamethasone as a second-line treatment for multiple myeloma.
A final decision by the European Commission usually takes about 60 days.
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Saul