Pfizer's Elrexfio gets EU nod for multiple myeloma
08 Dec 2023
Clinical ResultDrug ApprovalPhase 2Phase 3Accelerated Approval
Pfizer announced Friday that the European Commission has a granted conditional marketing authorisation for its BCMAxCD3 bispecific antibody Elrexfio (elranatamab). The treatment is indicated for adults with relapsed and refractory multiple myeloma who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy.
The decision comes after the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending conditional marketing authorisation for the treatment.
The EU approval was based on data from cohort A of the Phase II MagnetisMM-3 study involving heavily pretreated multiple myeloma patients who received Elrexfio as their first BCMA-directed therapy. An analysis of 123 patients showed an objective response rate of 61%, with a 71% probability of maintaining a response at 15 months.
Once-every-other-week dosing
Pfizer noted that the MagnetisMM-3 results also established once-every-other-week dosing with Elrexfio for all responding patients after 24 weeks of weekly therapy, "which means less time at the clinic and potentially greater long-term treatment tolerability." Among 50 responding patients who switched to every-other-week dosing at least six months prior to the data cut-off, 80% maintained or improved their response after the switch, with 38% attaining a complete response or better after the switch, according to findings published in Nature Medicine.
In the US, the bispecific antibody obtained an accelerated approval in August for use in fifth-line multiple myeloma patients. Jefferies analyst Akash Tewari estimates Elrexfio could generate about $1 billion in sales in 2030.
Meanwhile, other similar bispecific therapies currently on the EU market include Roche's Columvi (glofitamab), AbbVie's Tepkinly (epcoritamab) and Johnson & Johnson's Tecvayli (teclistamab) and Talvey (talquetamab), the latter directed against CD3 and GPRC5D. Speaking to FirstWord earlier this year, Daniel Sherbenou – associate professor of medicine-haematology at University of Colorado School of Medicine – suggested that dosing would play a key role in the successful uptake of these drugs.
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