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 names | elranatamab-bcmm |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a623045 |
| License data |
|
| Pregnancy category |
|
| Routes of administration | Subcutaneous |
| ATC code |
|
| 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.[8][12] Elranatamab is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager.[8][12][13][14] Elranatamab is given by subcutaneous injection.[8][12]
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).[12]
Elranatamab was approved for medical use in the United States in August 2023,[8][12][15][16] in the European Union in December 2023,[11] and in Canada in December 2023.[5]
Medical uses
[edit]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.[8][12]
Adverse effects
[edit]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.[12]
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.[12]
History
[edit]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.[12] 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.[12]
The FDA granted the application for elranatamab priority review, breakthrough therapy, and orphan drug designations;[12] and granted approval of Elrexfio to Pfizer Inc.[12]
Society and culture
[edit]Legal status
[edit]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.[10] The applicant for this medicinal product is Pfizer Europe MA EEIG.[10]
In 2023, elranatamab was approved for medical use in the United States,[8][12] in the European Union,[10][11] and in Canada.[5]
Brand names
[edit]Elranatamab is the international nonproprietary name.[17]
Elranatamab is sold under the brand name Elrexfio.[4][8][11]
References
[edit]- ^ a b "Elrexfio (elranatamab)". Therapeutic Goods Administration (TGA). 29 July 2024. Retrieved 12 October 2024.
- ^ "Therapeutic Goods (Poisons Standard—June 2024) Instrument 2024". Federal Register of Legislation. 30 May 2024. Retrieved 10 June 2024.
- ^ https://www.tga.gov.au/resources/prescription-medicines-registrations/elrexfio-pfizer-australia-pty-ltd
- ^ a b "Elrexfio Product information". Health Canada. 22 October 2009. Retrieved 3 March 2024.
- ^ a b c "Summary Basis of Decision for Elrexfio". Health Canada. 29 July 2024. Retrieved 28 August 2024.
- ^ "Details for: Elrexfio". Health Canada. 23 January 2024. Retrieved 3 March 2024.
- ^ "Regulatory Decision Summary for Elrexfio". Health Canada. 6 December 2023. Retrieved 2 April 2024.
- ^ a b c d e f g h "Elrexfio- elranatamab-bcmm injection, solution". DailyMed. 15 August 2023. Archived from the original on 18 August 2023. Retrieved 17 August 2023.
- ^ "Elrexfio- elranatamab-bcmm injection, solution". DailyMed. 16 August 2023. Archived from the original on 18 August 2023. Retrieved 17 August 2023.
- ^ a b c d "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.
- ^ a b c d "Elrexfio PI". Union Register of medicinal products. 8 December 2023. Retrieved 27 December 2023.
- ^ a b c d e f g h i j k l m "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.
This article incorporates text from this source, which is in the public domain.
- ^ 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.
- ^ 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.
- ^ "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.
- ^ Dhillon S (November 2023). "Elranatamab: First Approval". Drugs. 83 (17): 1621–1627. doi:10.1007/s40265-023-01954-w. PMID 37924427.
- ^ World Health Organization (2022). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 87". WHO Drug Information. 36 (1). hdl:10665/352794.
External links
[edit]- "Elranatamab (Code C146860)". NCI Thesaurus.
- 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
