Pomalidomide Celgene OKed in Europe
The European Commission has granted approval for US biotech firm Celgene’s (Nasdaq: CELG) Pomalidomide Celgene (pomalidomide), in combination with dexamethasone, for the treatment of relapsed and refractory multiple myeloma (rrMM) in adult patients who have received at least two prior therapies including both lenalidomide (Celgene's own Revlimid) and bortezomib (Johnson & Johnson/Takeda's Velcade) and have demonstrated disease progression on the last therapy.
Celgene intends to launch Pomalidomide Celgene in the European Union under the trade name Imnovid, following submission of a regulatory notification to the European Medicines Agency, whose advisory unit the Committee for Medicinal Products for Human Use recommended the drug’s approval (The Pharma Letter May 31), to change the trade name.
Blockbuster status anticipated
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