CHMP recommends Imnovid, bortezomib and dexamethasone to treat multiple myeloma

Celgene Corporation announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions for two triplet regimens based on Celgene’s proprietary IMiD medications, Revlimid (lenalidomide) and Imnovid (pomalidomide). The CHMP recommended approval of Imnovid in combination with bortezomib and dexamethasone (PVd), for the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide. The European Commission, which generally follows the recommendation of the CHMP, is expected to make its final decision in approximately two months.The CHMP positive opinion for PVd was based on the data from Optimssmm, the first prospective phase III trial to evaluate an Imnovid -based triplet regimen in patients who were previously treated with Revlimid, and who were, in the majority (70 percent), Revlimid refractory. This patient population represents a growing unmet medical need for which new treatment options are necessary. Results from Optimissmm showed that patients receiving PVd achieved a significantly longer PFS than those in the Vd treatment arm.

The CHMP positive opinion for PVd was based on the data from Optimssmm, the first prospective phase III trial to evaluate an Imnovid -based triplet regimen in patients who were previously treated with Revlimid, and who were, in the majority (70 percent), Revlimid refractory. This patient population represents a growing unmet medical need for which new treatment options are necessary. Results from Optimissmm showed that patients receiving PVd achieved a significantly longer PFS than those in the Vd treatment arm.