On October 12, 2023, the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) gave positive recommendation for the conditional marketing authorisation of elranatamab, also known as Elrexfio.
The treatment will be offered as a 40 mg/ml solution for injection. Its active component, elranatamab, is a bispecific monoclonal antibody that targets the CD3 receptor on T cells and BCMA on plasma cells, including those in malignant multiple myeloma.
Elranatamab is indicated 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.
EMA designated elranatamab as an orphan medicine for treating myeloma on July 29, 2021. This meant that Pfizer received scientific and regulatory support from EMA to advance this medicine to the stage where they can apply for marketing authorisation. The EMA accepted elranatamab’s marketing authorisation application in February 2023 and now the CHMP has given a positive recommendation.
The most common adverse reactions observed with elranatamab treatment include cytokine release syndrome, anaemia, neutropenia, fatigue, upper respiratory tract infection, and injection site reactions.