Pfizer’s immunotherapy ELREXFIO approved in EU for multiple myeloma

Pfizer Inc. has announced a significant development in the treatment of multiple myeloma, a type of cancer that affects plasma cells in the bone marrow. The European Commission (EC) has granted conditional marketing authorization for ELREXFIO (elranatamab), a targeted immunotherapy designed for adult patients with relapsed and refractory multiple myeloma (RRMM) who have received at least three prior therapies. This includes a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody, and have shown disease progression on the last therapy.

ELREXFIO is an off-the-shelf (ready-to-use) B-cell maturation antigen (BCMA)-CD3-directed bispecific antibody (BsAb) immunotherapy. It induces deep and durable responses, with a manageable tolerability profile as well as convenient subcutaneous dosing.

Chris Boshoff, Chief Oncology Research and Development Officer at Pfizer, highlighted the significance of ELREXFIO’s approval, providing a new treatment option for people with hard-to-treat multiple myeloma. Pfizer continues to explore the use of ELREXFIO in earlier lines of treatment, aiming to benefit a broader patient population.

The conditional marketing authorization for ELREXFIO is valid in all 27 EU member states, as well as Iceland, Liechtenstein, and Norway. The authorization is based on data from cohort A of the Phase 2 MagnetisMM-3 study, which showed meaningful responses among heavily pretreated RRMM patients.

The study demonstrated that ELREXFIO significantly reduced the risk of disease worsening or death (progression-free survival) compared to standard-of-care endocrine monotherapy. The results from MagnetisMM-3 also established once-every-other-week dosing with ELREXFIO for all responding patients after 24 weeks of weekly therapy, reducing clinic visits and potentially improving long-term treatment tolerability.

The most common adverse reactions to ELREXFIO include cytokine release syndrome (CRS), anemia, neutropenia, and fatigue. Due to the risk of CRS and immune effector cell-associated neurotoxicity syndrome (ICANS), patients are monitored for symptoms for 48 hours after administration of the two step-up doses within the ELREXFIO dosing schedule.

ELREXFIO is a significant addition to the treatment options for multiple myeloma, particularly for patients with relapsed and refractory forms of the disease. The approval by the European Commission marks a key milestone in the fight against multiple myeloma, offering hope and new treatment possibilities for patients across Europe.