Elranatamab (Elrexfio)

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General information

Class/mechanism from the NCI Drug Dictionary: A bispecific monoclonal antibody against human CD3, a T-cell surface antigen, and human B-cell maturation antigen (BCMA; TNFRSF17), a tumor-associated antigen (TAA) expressed on plasma cells, with potential antineoplastic activity. Upon administration, elranatamab binds to both CD3 on T cells and BCMA expressed on malignant plasma cells. This results in the cross-linking of T cells and tumor cells, and induces a potent cytotoxic T-lymphocyte (CTL) response against BCMA-expressing plasma cells.
Route: IV
Extravasation: no information

Toxicity management

  • REMS website TBA

Diseases for which it is established

History of changes in FDA indication

  • 2023-08-14: Granted accelerated approval for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. (Based on MagnetisMM-3)

History of changes in EMA indication

  • 2023-10-12: CHMP recommends conditional marketing authorisation as Elrexfio. Elrexfio is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.

Also known as

  • Code names: PF-06863135, RN-613
  • Generic name: elranatamab-bcmm
  • Brand name: Elrexfio