CHMP recommends Revlimid, 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 an expanded indication of Revlimid as combination therapy with bortezomib and dexamethasone (RVd) for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. 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 Revlimid was based on the data from SWOG S0777, a phase III trial evaluating the triplet combination of Revlimid, bortezomib and dexamethasone (RVd) in adult patients with previously untreated multiple myeloma, without an intent for immediate autologous stem cell transplant (ASCT). Results from SWOG S0777 showed statistically significant progression-free (PFS) and overall survival improvements in patients treated with RVd compared to those treated with Revlimid and dexamethasone alone (Rd). The choice of treatment in a first-line therapy setting is important as patients progressively become less responsive to therapy and experience shorter periods of remission at later lines of treatment.