Chemistry:Elranatamab
Elranatamab, sold under the brand name Elrexfio, is a medication used for the treatment of multiple myeloma.[1][2] Elranatamab is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager.[1][2][3][4] Elranatamab is given by subcutaneous injection.[1][2]
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).[2]
Elranatamab was approved for medical use in the United States in August 2023,[1][2][5][6] in the European Union in December 2023,[7] and in Canada in December 2023.[8]
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][2]
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.[2]
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.[2]
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.[2] 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.[2]
The FDA granted the application for elranatamab priority review, breakthrough therapy, and orphan drug designations;[2] and granted approval of Elrexfio to Pfizer Inc.[2]
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.[9] The applicant for this medicinal product is Pfizer Europe MA EEIG.[9]
In 2023, elranatamab was approved for medical use in the United States,[1][2] in the European Union,[9][7] and in Canada.[8]
Brand names
Elranatamab is the international nonproprietary name.[10]
Elranatamab is sold under the brand name Elrexfio.[11][1][7]
References
- ↑ 1.0 1.1 1.2 1.3 1.4 1.5 1.6 Cite error: Invalid
<ref>tag; no text was provided for refs namedElrexfio FDA label - ↑ 2.00 2.01 2.02 2.03 2.04 2.05 2.06 2.07 2.08 2.09 2.10 2.11 2.12 "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.
This article incorporates text from this source, which is in the public domain.
- ↑ "An Embarrassment of Riches: Three FDA-Approved Bispecific Antibodies for Relapsed Refractory Multiple Myeloma". Blood Cancer Discovery 4 (6): 433–436. November 2023. doi:10.1158/2643-3230.BCD-23-0176. PMID 37824758.
- ↑ "Bispecific Antibodies for Multiple Myeloma: Recent Advancements and Strategies for Increasing Their Efficacy". Frontiers in Bioscience (Landmark Edition) 29 (6): 216. June 2024. 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.
- ↑ "Elranatamab: First Approval". Drugs 83 (17): 1621–1627. November 2023. doi:10.1007/s40265-023-01954-w. PMID 37924427. https://figshare.com/articles/online_resource/Elranatamab_First_Approval/24201675.
- ↑ 7.0 7.1 7.2 Cite error: Invalid
<ref>tag; no text was provided for refs namedElrexfio PI - ↑ 8.0 8.1 Cite error: Invalid
<ref>tag; no text was provided for refs namedElrexfio CA PI SBD - ↑ 9.0 9.1 9.2 "Elrexfio EPAR". 12 October 2023. https://www.ema.europa.eu/en/medicines/human/EPAR/elrexfio. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 87". WHO Drug Information 36 (1). 2022.
- ↑ Cite error: Invalid
<ref>tag; no text was provided for refs namedElrexfio PI CA
This article incorporates public domain material from the United States Department of Health and Human Services website http://www.fda.gov.
External links
- "Elranatamab (Code C146860)". https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C146860.
- 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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