Elranatamab

Elranatamab, sold under the brand name Elrexfio, is a medication used for the treatment of multiple myeloma.[1][3] Elranatamab is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager.[1][3] Elranatamab is administered subcutaneously.[1][3]

Elranatamab
Clinical data
Trade namesElrexfio
Other nameselranatamab-bcmm
License data
Routes of
administration		Subcutaneous
ATC code
  • None
Legal status
Legal status
Identifiers
CAS Number
DrugBank
UNII
KEGG
Chemical and physical data
FormulaC6440H9958N1738O2010S49
Molar mass145461.60 g·mol−1

The most common side effects include cytokine release syndrome, fatigue, injection site reaction, diarrhea, upper respiratory tract infection, musculoskeletal pain, pneumonia, decreased appetite, rash, cough, nausea, and pyrexia (fever).[3]

Elranatamab was approved for medical use in the United States in August 2023.[1][3][4]

Medical uses

Elranatamab is indicated for the treatment of 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.[1][3]

Adverse effects

The most common adverse reactions include cytokine release syndrome, fatigue, injection site reaction, diarrhea, upper respiratory tract infection, musculoskeletal pain, pneumonia, decreased appetite, rash, cough, nausea, and pyrexia.[3]

The US Food and Drug Administration (FDA) prescribing information for elranatamab has a boxed warning for life threatening or fatal cytokine release syndrome and neurologic toxicity, including immune effector cell-associated neurotoxicity.[3]

History

The safety and effectiveness of elranatamab was evaluated in MagnetisMM-3 (NCT04649359), an open-label, single-arm, multi-center study that included participants with relapsed/refractory multiple myeloma who are refractory to at least one proteasome inhibitor, one immunomodulatory drug, and one anti-CD38 antibody.[3] Overall, the study consisted of 97 participants naïve to prior BCMA-directed therapy and who had previously received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.[3]

The FDA granted the application for elranatamab priority review, breakthrough therapy, and orphan drug designations;[3] and granted approval of Elrexfio to Pfizer Inc.[3]

References
  1. "Elrexfio- elranatamab-bcmm injection, solution". DailyMed. 15 August 2023. Archived from the original on 18 August 2023. Retrieved 17 August 2023.
  2. "Elrexfio- elranatamab-bcmm injection, solution". DailyMed. 16 August 2023. Archived from the original on 18 August 2023. Retrieved 17 August 2023.
  3. "FDA grants accelerated approval to elranatamab-bcmm for multiple myeloma". U.S. Food and Drug Administration (FDA) (Press release). 14 August 2023. Retrieved 14 August 2023. Public Domain This article incorporates text from this source, which is in the public domain.
  4. "Pfizer's Elrexfio Receives U.S. FDA Accelerated Approval for Relapsed or Refractory Multiple Myeloma" (Press release). Pfizer. 14 August 2023. Retrieved 17 August 2023 – via Business Wire.

Public Domain This article incorporates public domain material from the United States Department of Health and Human Services.

Clinical trial number NCT04649359 for "MagnetisMM-3: Study Of Elranatamab (PF-06863135) Monotherapy in Participants With Multiple Myeloma Who Are Refractory to at Least One PI, One IMiD and One Anti-CD38 mAb" at ClinicalTrials.gov


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