Pfizer's ELREXFIO Receives Conditional Marketing Authorization From European Commission

(RTTNews) - Pfizer Inc. (PFE) on Friday announced that its prescription medication, ELREXFIO (elranatamab) has received conditional marketing authorization from the European Commission (EC) to treat adult patients with relapsed and refractory multiple myeloma (RRMM).

The authorization is based on data from cohort A of the Phase 2 MagnetisMM-3 study, which showed significant responses among heavily pretreated RRMM individuals who received ELREXFIO as their first BCMA-directed therapy.

The authorization is valid in all 27 EU member states and Norway, Iceland, and Liechtenstein.

ELREXFIO is a subcutaneously delivered B-cell maturation antigen (BCMA)-CD3-directed bispecific antibody (BsAb) immunotherapy, and it activates T-cells to destroy myeloma cells.

The company also stated that ELREXFIO is available only through the ELREXFIO Risk Evaluation and Mitigation Strategy (REMS) Program due to the risk of cytokine release syndrome (CRS) and neurologic problems.