CHMP recommends Elrexfio (elranatamab),a bispecific monoclonal antibody, to treat r/r multiple myeloma.- Pfizer
The Committee for Medicinal Products for Human Use (CHMP) adopted on 12 October 2023, a positive opinion, recommending the granting of a conditional1 marketing authorisation for the medicinal product Elrexfio, intended for the treatment of multiple myeloma. The applicant for this medicinal product is Pfizer Europe MA EEIG.
Elrexfio will be available as a 40 mg/ml solution for injection. The active substance of Elrexfio is elranatamab, a bispecific monoclonal antibody that targets the CD3 receptor expressed on the surface of T cells and BCMA expressed on the surface of plasma cells, including malignant multiple myeloma cells.
The benefit of Elrexfio is its ability to bring about a partial or complete response in patients with relapsed or refractory multiple myeloma, as shown in a phase II, open-label study. The most common side effects are cytokine release syndrome, anaemia, neutropenia, fatigue, upper respiratory tract infection and injection site reactions.