Elranatamab

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Elranatamab
Monoclonal antibody
TypeBi-specific T-cell engager
TargetBCMA-expressing multiple myeloma cells and CD3-expressing T-cells
Names
Trade namesElrexfio
Other nameselranatamab-bcmm
Clinical data
Routes of
use		Subcutaneous
External links
AHFS/Drugs.comMonograph
MedlinePlusa623045
Legal
License data
Legal status
Chemical and physical data
FormulaC6440H9958N1738O2010S49
Molar mass145461.60 g·mol−1

Elranatamab, sold under the brand name Elrexfio, is a medication used to treat multiple myeloma.[7][9][10][11] It is given by injection under the skin.[7][9]

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).[9] Elranatamab is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager.[7][9]

Elranatamab was approved for medical use in the United States and Europe in 2023,[7][9][12][6] and Canada in 2024.[2]

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.[7][9]

Side 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.[9]

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.[9]

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.[9] 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.[9]

The FDA granted the application for elranatamab priority review, breakthrough therapy, and orphan drug designations;[9] and granted approval of Elrexfio to Pfizer Inc.[9]

Society and culture

Legal status

In October 2023, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a conditional marketing authorization for the medicinal product Elrexfio, intended for the treatment of multiple myeloma.[13] The applicant for this medicinal product is Pfizer Europe MA EEIG.[13]

Elranatamab was approved for medical use in the United States in August 2023,[7][9] in the European Union in December 2023,[6] and in Canada in January 2024.[2]

Brand names

Elranatamab is the international nonproprietary name.[14]

Elranatamab is sold under the brand name Elrexfio.[2][7][6]

References

  1. ↑ "Therapeutic Goods (Poisons Standard—June 2024) Instrument 2024". Federal Register of Legislation. 30 May 2024. Archived from the original on 10 June 2024. Retrieved 10 June 2024.
  2. ↑ 2.0 2.1 2.2 2.3 "Elrexfio Product information". Health Canada. 22 October 2009. Archived from the original on 3 March 2024. Retrieved 3 March 2024.
  3. ↑ "Notice: Multiple additions to the Prescription Drug List (PDL) [2024-02-28]". Health Canada. 28 February 2024. Archived from the original on 2024-03-02. Retrieved 2 March 2024.
  4. ↑ "Details for: Elrexfio". Health Canada. 23 January 2024. Archived from the original on 3 March 2024. Retrieved 3 March 2024.
  5. ↑ "Regulatory Decision Summary for Elrexfio". Drug and Health Products Portal. 6 December 2023. Retrieved 2 April 2024.
  6. ↑ 6.0 6.1 6.2 6.3 "Elrexfio PI". Union Register of medicinal products. 8 December 2023. Archived from the original on 13 December 2023. Retrieved 27 December 2023.
  7. ↑ 7.0 7.1 7.2 7.3 7.4 7.5 7.6 7.7 "Elrexfio- elranatamab-bcmm injection, solution". DailyMed. 15 August 2023. Archived from the original on 18 August 2023. Retrieved 17 August 2023.
  8. ↑ "Elrexfio- elranatamab-bcmm injection, solution". DailyMed. 16 August 2023. Archived from the original on 18 August 2023. Retrieved 17 August 2023.
  9. ↑ 9.00 9.01 9.02 9.03 9.04 9.05 9.06 9.07 9.08 9.09 9.10 9.11 9.12 "FDA grants accelerated approval to elranatamab-bcmm for multiple myeloma". U.S. Food and Drug Administration (FDA) (Press release). 14 August 2023. Archived from the original on 15 August 2023. Retrieved 14 August 2023. Public Domain This article incorporates text from this source, which is in the public domain.
  10. ↑ Grosicki S, Bednarczyk M, Kociszewska K (2023). "Elranatamab: a new promising BispAb in multiple myeloma treatment". Expert Review of Anticancer Therapy. 23 (8): 775–782. doi:10.1080/14737140.2023.2236303. PMID 37434334. S2CID 259832018.
  11. ↑ Dhillon S (November 2023). "Elranatamab: First Approval". Drugs. 83 (17): 1621–1627. doi:10.1007/s40265-023-01954-w. PMID 37924427. S2CID 265018550. Archived from the original on 2024-07-09. Retrieved 2024-06-10.
  12. ↑ "Pfizer's Elrexfio Receives U.S. FDA Accelerated Approval for Relapsed or Refractory Multiple Myeloma" (Press release). Pfizer. 14 August 2023. Archived from the original on 17 August 2023. Retrieved 17 August 2023 – via Business Wire.
  13. ↑ 13.0 13.1 "Elrexfio EPAR". European Medicines Agency (EMA). 12 October 2023. Archived from the original on 9 July 2024. Retrieved 27 December 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  14. ↑ World Health Organization (2022). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 87". WHO Drug Information. 36 (1). hdl:10665/352794.

 This article incorporates public domain material from the United States Department of Health and Human Services website http://www.fda.gov.

External links

Identifiers:
  • "Elranatamab (Code C146860)". NCI Thesaurus. Archived from the original on 2023-12-27. Retrieved 2024-06-10.
  • 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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