EU Conditionally Approves Pfizer’s ELREXFIO (elranatamab) for Relapsed & Refractory Multiple Myeloma

Summary:

The conditional marketing authorization for ELREXFIO® (elranatamab) is for the treatment of adult patients 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.

ELREXFIO is an off-the-shelf B-cell maturation antigen (BCMA)-CD3-directed bispecific antibody immunotherapy using subcutaneous dosing.

Authorization was based on data from Cohort A of the Phase 2 MagnetisMM-3 study. In an analysis of these patients (n=123), the objective response rate was 61%, with a 71% probability of maintaining a response at 15 months.

The results also established once-every-other-week dosing with ELREXFIO for all responding patients after 24 weeks of weekly therapy. Among responding patients who switched to every-other-week dosing at least 6 months prior to the data cut-off date (n=50), 80% maintained or improved their response after the switch, with 38% attaining a complete response or better after the switch.

The most common adverse reaction to ELREXFIO is the cytokine release syndrome (58%). Due to this risk and immune effector cell-associated neurotoxicity syndrome, patients should be monitored for signs and symptoms for 48 hours after administration of each of the two step-up doses within the ELREXFIO dosing schedule and instructed to remain in proximity of a healthcare facility. In the EU, precautionary hospitalization is not required. Patients are not required to stay near a healthcare facility for the 76-mg first treatment dose.

The European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) recommended the conditional marketing authorization on October 12, 2023.

More than 50,000 Europeans are diagnosed with multiple myeloma each year.

Notification link: European Commission Approves Pfizer’s ELREXFIO® for Relapsed and Refractory Multiple Myeloma