The European Commission has granted conditional marketing authorisation for elranatamab, also known as Elrexfio® marketed by the pharmaceutical company Pfizer.
This follows an earlier positive recommendation from the European Medicines Agency (EMA – the EU drug licensing body) Committee for Medicinal Products for Human Use (CHMP), after which the European Commission had 60 days to ratify.
The decision means that the product is safe and effective to prescribe in myeloma patients in the 27 EU member states, plus Norway, Iceland and Liechtenstein. However, for patients to access it, it usually requires a funding decision by national health authorities.
Elranatamab is a bi-specific monoclonal antibody targeting BCMA expressed on the surface of the myeloma cells and CD3 on the surface of T-cells (a type of immune cell). By attaching to both at the same time, it activates the T-cells to find and kill the myeloma cells.
Elranatamab is specifically approved as a monotherapy for adult patients with relapsed and refractory myeloma who have undergone a minimum of three prior therapies, including an immunomodulatory agent (such as lenalidomide, pomalidomide or thalidomide), a proteasome inhibitor (such as bortezomib, carfilzomib or ixazomib) and an anti-CD38 monoclonal antibody (such as daratumumab or isatuximab), and have shown disease progression on the last therapy.
The European Commission approval is based on data from a specific group of patients (cohort A) assessed in a clinical trial called MagnetisMM-3.
Watch the video of Prof. Dr. Mohamad Mohty, Professor and Head of the haematology and cellular therapy department at the Saint-Antoine Hospital in Paris, France, explaining the efficacy of elranatamab in the MagnetisMM-3 trial.