EC approves Pfizer’s Elrexfio for relapsed and refractory multiple myeloma
Betsy Goodfellow | December 12, 2023 | News story | Medical Communications | Elrexfio, European Commission, Oncology, Pfizer, multiple myeloma
Pfizer has announced that the European Commission (EC) has granted conditional marketing authorisation for Elrexfio (elranatamab) for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM) who have had at least three prior therapies.
Elrexfio is a ready-to-use B-cell maturation antigen (BCMA)-CD3-directed bispecific antibody (BsAb) immunotherapy that has been shown to induce deep and durable responses. It has a manageable tolerability profile and is available for subcutaneous dosing.
The conditional marketing authorisation is valid in all 27 EU member states, as well as Iceland, Liechtenstein and Norway, and follows European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) recommendation in October 2023.
The approval follows data from cohort A of the phase 2 MagnetisMM-3 study, which showed meaningful responses among heavily pretreated RRMM patients. The most common adverse reactions to the drug included: cytokine release syndrome, anaemia, neutropenia, fatigue, upper respiratory tract infection, injection site reaction, diarrhoea, pneumonia, thrombocytopenia, lymphopenia, decreased appetite, rash, joint pain, fever, hypokalemia, nausea, dry skin, pneumonia, sepsis, urinary tract infection, dyspnea and pyrexia.
Chris Boshoff, chief oncology research and development officer and executive vice president at Pfizer, stated: “More than 50,000 Europeans are diagnosed with multiple myeloma each year and, too often, they face relapse and treatment resistance. Today’s approval provides a new, broadly available option for people with hard-to-treat multiple myeloma, and we continue to explore the use of Elrexfio in earlier lines of treatment so that more people may ultimately benefit from this therapy.”
Betsy Goodfellow
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