EU CHMP recommends approval of Empliciti (elotuzumab) plus lenalidomide and dexamethasone for multiple myeloma- BMS

The EMA Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Empliciti (elotuzumab), from BMS, intended for the treatment of multiple myeloma. Empliciti is indicated in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. It is proposed that Empliciti therapy should be initiated and supervised by physicians experienced in the treatment of multiple myeloma.

The CHMP’s recommendation is based on a randomised, open-label Phase III study evaluating Empliciti in combination with lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone in patients with relapsed or refractory multiple myeloma. The trial enrolled 646 patients whose multiple myeloma came back after, or did not respond to, previous treatment. In patients also taking Empliciti, the disease progressed more slowly (difference in medians of 4.2 months) than in patients taking only lenalidomide and dexamethasone. In addition, 78.5% of patients taking Empliciti with lenalidomide and dexamethasone saw a complete or partial shrinkage of their tumours compared to 65.5% in those only taking lenalidomide and dexamethasone.

Comment: Darzalex (daratumumab) from Janssen Biotech, approved earlier this month, is the only other FDA-approved monoclonal antibody for the treatment of patients with multiple myeloma. Other recently approved drugs for multiple myeloma are Pomalyst (pomalidomide) from Celgene and Darzalex (daratumumab) from Janssen Biotech. The potential market leader may be Kyprolis (carfilzomib) from Amgen.