Celgene International's oral anti-cancer therapy Pomalidomide has won European Commission approval as treatment for patients with relapsed/refractory multiple myeloma (rrMM), a rare form of blood cancer, in combination with dexamethasone.
Pomalidomide is intended for rrMM patients who have received a minimum of two prior therapies such as lenalidomide and bortezomib and in whom the disease progressed on the last therapy.
Subsequent to submitting a regulatory notification to the European Medicines Agency (EMA) to change the trade name, Pomalidomide Celgene is expected to be launched in the EU under the trade name IMNOVID.
Celgene Europe, the Middle East and Africa (EMEA) president Alan Colowick said, "With today's approval, Celgene becomes one of the few companies to deliver treatments across all stages of multiple myeloma, right from the start at diagnosis, through to the support that pomalidomide can now offer late-stage multiple myeloma patients who have exhausted other treatment options."
The results from the MM-003 study, a Phase III, randomized (2:1), open-label study that was conducted in 455 patients, supported the Commission's decision.
In the multi-center study, pomalidomide plus low-dose dexamethasone patient group demonstrated significantly improved median progression-free survival of 15.7 weeks (p<0.001) along with significantly improved median overall survival against those treated with high-dose dexamethasone only.
