Elranatamab

Last updated

Elranatamab
Monoclonal antibody
Type Bi-specific T-cell engager
Target BCMA-expressing multiple myeloma cells and CD3-expressing T-cells
Clinical data
Trade names Elrexfio
Other nameselranatamab-bcmm
AHFS/Drugs.com Monograph
MedlinePlus a623045
License data
Routes of
administration 		Subcutaneous
ATC code
  • None
Legal status
Legal status
Identifiers
CAS Number
DrugBank
UNII
KEGG
Chemical and physical data
Formula C6440H9958N1738O2010S49
Molar mass 145461.60 g·mol−1

Elranatamab, sold under the brand name Elrexfio, is a medication used for the treatment of multiple myeloma. [6] [10] Elranatamab is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager. [6] [10] [11] [12] Elranatamab is given by subcutaneous injection. [6] [10]

Contents

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). [10]

Elranatamab was approved for medical use in the United States in August 2023, [6] [10] [13] [14] in the European Union in December 2023, [9] and in Canada in December 2023. [3]

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. [6] [10]

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. [10]

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. [10]

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. [10] 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. [10]

The FDA granted the application for elranatamab priority review, breakthrough therapy, and orphan drug designations; [10] and granted approval of Elrexfio to Pfizer Inc. [10]

Society and culture

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. [8] The applicant for this medicinal product is Pfizer Europe MA EEIG. [8]

In 2023, elranatamab was approved for medical use in the United States, [6] [10] in the European Union, [8] [9] and in Canada. [3]

Brand names

Elranatamab is the international nonproprietary name. [15]

Elranatamab is sold under the brand name Elrexfio. [2] [6] [9]

Related Research Articles

<span class="mw-page-title-main">Multiple myeloma</span> Cancer of plasma cells

Multiple myeloma (MM), also known as plasma cell myeloma and simply myeloma, is a cancer of plasma cells, a type of white blood cell that normally produces antibodies. Often, no symptoms are noticed initially. As it progresses, bone pain, anemia, renal insufficiency, and infections may occur. Complications may include hypercalcemia and amyloidosis.

<span class="mw-page-title-main">B-cell maturation antigen</span> Protein-coding gene in the species Homo sapiens

B-cell maturation antigen, also known as tumor necrosis factor receptor superfamily member 17 (TNFRSF17), is a protein that in humans is encoded by the TNFRSF17 gene.

<span class="mw-page-title-main">Bi-specific T-cell engager</span> Class of artificial monoclonal antibodies

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Daratumumab, sold under the brand name Darzalex among others, is an anti-cancer monoclonal antibody medication. It binds to CD38, which is overexpressed in multiple myeloma cells. Daratumumab was originally developed by Genmab, but it is now being jointly developed by Genmab along with the Johnson & Johnson subsidiary Janssen Biotech, which acquired worldwide commercialization rights to the drug from Genmab.

<span class="mw-page-title-main">Isatuximab</span> Monoclonal antibody

Isatuximab, sold under the brand name Sarclisa, is a monoclonal antibody (mAb) medication for the treatment of multiple myeloma.

<span class="mw-page-title-main">Ixazomib</span> Chemical compound

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<span class="mw-page-title-main">Melphalan flufenamide</span> Alkylating type cancer drug

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Daratumumab/hyaluronidase, sold under the brand name Darzalex Faspro, is a fixed-dose combination medication for the treatment of adults with newly diagnosed or relapsed/refractory multiple myeloma. It is a combination of daratumumab and hyaluronidase. It is administered via subcutaneous injection.

Brexucabtagene autoleucel, sold under the brand name Tecartus, is a cell-based gene therapy medication for the treatment of mantle cell lymphoma (MCL) and acute lymphoblastic leukemia (ALL).

Belantamab mafodotin, sold under the brand name Blenrep, is a monoclonal antibody for the treatment of relapsed and refractory multiple myeloma.

Idecabtagene vicleucel, sold under the brand name Abecma, is a cell-based gene therapy to treat multiple myeloma.

Ciltacabtagene autoleucel, sold under the brand name Carvykti, is an anti-cancer medication used to treat multiple myeloma. Ciltacabtagene autoleucel is a BCMA -directed genetically modified autologous chimeric antigen receptor (CAR) T-cell therapy. Each dose is customized using the recipient's own T-cells, which are collected and genetically modified, and infused back into the recipient.

Mosunetuzumab, sold under the brand name Lunsumio, is a monoclonal antibody used for the treatment of follicular lymphoma. It bispecifically binds CD20 and CD3 to engage T-cells. It was developed by Genentech.

Teclistamab, sold under the brand name Tecvayli, is a human bispecific monoclonal antibody used for the treatment of relapsed and refractory multiple myeloma. It is a bispecific antibody that targets the CD3 receptor expressed on the surface of T-cells and B-cell maturation antigen (BCMA), which is expressed on the surface of malignant multiple myeloma B-lineage cells.

Talquetamab, sold under the brand name Talvey, is a humanized monoclonal antibody used for the treatment of multiple myeloma. It is a bispecific GPRC5D-directed CD3 T-cell engager. Talquetamab is a bispecific antibody against two targets: human CD3, a T-cell surface antigen, and human G-protein coupled receptor family C group 5 member D (GPRC5D), a tumor-associated antigen with potential antineoplastic activity. Talquetamab binds both targets, drawing the T cells close to the tumor cells, causing a cytotoxic T-lymphocyte response. It is being developed by Janssen Pharmaceuticals.

Glofitamab, sold under the brand name Columvi, is a bispecific monoclonal antibody used for the treatment of large B-cell lymphoma. It is a bispecific CD20-directed CD3 T-cell engager developed by Roche.

Epcoritamab, sold under the brand name Epkinly, is a monoclonal antibody anticancer medication used for the treatment of diffuse large B-cell lymphoma. Epcoritamab is a bispecific CD20-directed CD3 T-cell engager. Epcoritamab was co-developed by AbbVie and Genmab.

Odronextamab, sold under the brand name Ordspono, is a CD20 x CD3 bispecific monoclonal antibody that is used for the treatment of follicular lymphoma or diffuse large B-cell lymphoma. It was developed by Regeneron Pharmaceuticals.

References

  1. ↑ "Therapeutic Goods (Poisons Standard—June 2024) Instrument 2024". Federal Register of Legislation. 30 May 2024. Retrieved 10 June 2024.
  2. 1 2 "Elrexfio Product information". Health Canada . 22 October 2009. Retrieved 3 March 2024.
  3. 1 2 3 "Summary Basis of Decision for Elrexfio". Health Canada . 29 July 2024. Retrieved 28 August 2024.
  4. ↑ "Details for: Elrexfio". Health Canada . 23 January 2024. Retrieved 3 March 2024.
  5. ↑ "Regulatory Decision Summary for Elrexfio". Health Canada . 6 December 2023. Retrieved 2 April 2024.
  6. 1 2 3 4 5 6 7 8 "Elrexfio- elranatamab-bcmm injection, solution". DailyMed. 15 August 2023. Archived from the original on 18 August 2023. Retrieved 17 August 2023.
  7. ↑ "Elrexfio- elranatamab-bcmm injection, solution". DailyMed. 16 August 2023. Archived from the original on 18 August 2023. Retrieved 17 August 2023.
  8. 1 2 3 4 "Elrexfio EPAR". European Medicines Agency (EMA). 12 October 2023. Retrieved 27 December 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  9. 1 2 3 4 "Elrexfio PI". Union Register of medicinal products. 8 December 2023. Retrieved 27 December 2023.
  10. 1 2 3 4 5 6 7 8 9 10 11 12 13 "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.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  11. ↑ Firestone R, Lesokhin AM, Usmani SZ (November 2023). "An Embarrassment of Riches: Three FDA-Approved Bispecific Antibodies for Relapsed Refractory Multiple Myeloma". Blood Cancer Discovery. 4 (6): 433–436. doi:10.1158/2643-3230.BCD-23-0176. PMC   10618718 . PMID   37824758.
  12. ↑ Wang M, Wang C, Deng J, Wang H, Sun C, Luo S, et al. (June 2024). "Bispecific Antibodies for Multiple Myeloma: Recent Advancements and Strategies for Increasing Their Efficacy". Frontiers in Bioscience (Landmark Edition). 29 (6): 216. doi:10.31083/j.fbl2906216. PMID   38940040.
  13. ↑ "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.
  14. ↑ Dhillon S (November 2023). "Elranatamab: First Approval". Drugs. 83 (17): 1621–1627. doi:10.1007/s40265-023-01954-w. PMID   37924427.
  15. ↑ World Health Organization (2022). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 87". WHO Drug Information. 36 (1). hdl: 10665/352794 .

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