The European Medicines Agency's (EMA) Committee for Human Medicines (CHMP) has recommended conditional marketing authorization for ELREXFIOTM (elranatamab) as a standalone treatment for adult patients with relapsed and refractory multiple myeloma. These patients must have undergone at least three prior therapies and experience worsened cancer since their last treatment.
Although several new medicines have already been developed and approved for multiple myeloma treatment in recent years, there is a need for additional options for patients who have failed to respond to the three main classes of medicines, including immunomodulatory agents, proteasome inhibitors, and monoclonal antibodies.
Elranatamab, the active component of Elrexfio, is a monoclonal antibody that simultaneously targets two proteins. The medication binds to B-cell maturation antigen (BCMA) found on multiple myeloma cells and CD3, a protein present in T cells of the immune system. This interaction activates T cells to eliminate multiple myeloma cells.
Elrexfio received support from EMA's PRIority MEdicines (PRIME) scheme, designed to provide early and enhanced scientific and regulatory assistance to medicines addressing unmet medical needs. Read the full announcement from the EMA to learn more.