European Medicines Agency recommends marketing authorization for elranatamab

On October 13, 2023, the Committee for Medicinal Products for Human Use (CHMP), part of the European Medicines Agency (EMA), announced the recommended marketing authorization for elranatamab. The United States Food and Drug Administration (FDA) previously granted approval under the accelerated approval program in August 2023.

Elranatamab is a novel B-cell maturation antigen CD3-directed bispecific antibody intended for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received ≥3 prior lines of therapy and have experienced disease progression during the most recent treatment. Elranatamab binds to BCMA on myeloma cells and CD3 on T-cells, leading to T-cell activation and myeloma cell death.

The recommendation was based on the results from the phase II MagnetisMM-3 trial (NCT04649359), which enrolled 123 patients.

• The objective response rate was 61%.
• There was a 72% probability of maintaining response at 15 months.
• After 24 weeks of weekly infusions, an every-other-week dosing schedule was established.
• Of the patients who switched to the every-other-week dosing schedule (n = 50), 80% maintained or improved their response and 38% experienced a complete response.
• The ten most common adverse events are shown in Figure 1.

CRS, cytokine release syndrome; RTI, respiratory tract infection.
*Adapted from Pfizer, 2023

The European Commission is due to make a legally binding decision in the coming months. If granted, this decision will apply to all 27 member states. Ongoing trials, such as the MagnetisMM-5 (NCT05020236), -6 (NCT05623020), and -7 (NCT05317416), are exploring the use of elranatamab as a monotherapy and in combination with standard or novel therapies.