Data from Pharmawand - Curated by EPG Health - Date added 10 August 2013
Celgene International Sàrl, has announced that the European Commission (EC) has granted approval for 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 and bortezomib and have demonstrated disease progression on the last therapy.
The EC’s decision was based on the results from the MM-003 study, a phase III, multi-center, randomized (2:1), open-label study in 455 patients. The results demonstrated significantly improved median progression-free survival of 15.7 weeks (p<0.001) for patients with rrMM who were treated with pomalidomide plus low-dose dexamethasone, compared with 8.0 weeks (p<0.001) for those treated with high-dose dexamethasone only (data cutoff 07/09/12). Median overall survival was also significantly improved for the pomalidomide plus low-dose dexamethasone arm, compared with high-dose dexamethasone only, (median not reached vs. 34 weeks; p<0.001.
Celgene intends to launch Pomalidomide Celgene in the EU under the trade name “"Imnovid" following submission of a regulatory notification to the European Medicines Agency (EMA) to change the trade name.
Pomalidomide is approved in the US as Pomalyst for Multiple Myeloma.0>