Isatuximab recommended for approval in combination with carfilzomib and dexamethasone in relapsed multiple myeloma

The European Medicines Agency’s Committee for Medicinal Products for Human Use issued positive opinion for second indication for isatuximab in combination with carfilzomib and dexamethasone (Kd) for multiple myeloma (MM) who have received at least one prior therapy. MM is the second most common hematologic malignancy and despite available treatments, remains an incurable malignancy associated with significant patient burden. Since MM does not have a cure, most patients will relapse. Isatuximab is a monoclonal antibody that binds to a specific epitope on the CD38 receptor, which is highly and uniformly expressed on the surface of MM cells. It functions through multiple...