Pfizer’s Elrexfio for treating multiple myeloma has been granted conditional market approval from the European Commission (EC), following a Phase II trial in patients who had previously undergone multiple treatments.
Known as elranatamab, Elrexfio is a targeted immunotherapy intended for use in patients living with RRMM and have already received at least three other therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.
The EC approval followed data from one of the cohorts of a Phase II study (NCT04649359) named MagnetisMM-3 in which 61% of patients treated with Elrexfio saw an objective response to the treatment, with a 71% chance of maintaining that response for 15 months.
The company said the trial results also indicated that patients could switch to less frequent biweekly dosing, which will help make the treatment more tolerable for long-term treatment. Serious side effects noted in the study included sepsis, pneumonia and anaemia, among others.
Chris Boshoff, executive vice president for Pfizer, said: “More than 50,000 Europeans are diagnosed with multiple myeloma each year, and too often, they face relapse and treatment resistance.
“This 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.”
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The announcement comes after Elrexfio received accelerated approval from the US Food and Drug Administration (FDA) in August 2023, setting it up to enter a market already dominated by competitors such as Janssen’s BCMA-CD3 bispecific antibody Tecvayli (teclistamab).
GlobalData’s Pharmaceutical Intelligence Centre predicts that, by the end of 2024, sales of Elrexfio will have reached an estimated $114m, with this figure expected to climb to around $536m by the end of 2029, of which $455m is expected to come from the US market. Within the same timeframe, Tecvayli is expected to see sales of $4.7bn.
GlobalData is the parent company of Clinical Trials Arena.
The approval means the treatment will be available across all 27 EU member states. In addition, Elrexfio has also received approval in Switzerland and Brazil under a framework, named Project Orbis, designed to speed up the review of oncology drugs among international partners.
At the same time, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has granted Elrexfio an innovative medicine designation that allows patients with severe conditions early access to the treatment.