Clinical data | |
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Trade names | Elrexfio |
Other names | elranatamab-bcmm |
AHFS/ Drugs.com | Monograph |
MedlinePlus | a623045 |
License data |
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Routes of administration | Subcutaneous |
ATC code |
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Legal status | |
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Identifiers | |
CAS Number | |
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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. [5] [8] [9] [10] Elranatamab is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager. [5] [8] Elranatamab is administered subcutaneously. [5] [8]
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). [8]
Elranatamab was approved for medical use in the United States in August 2023, [5] [8] [11] in the European Union in December 2023, [7] and in Canada in January 2024. [1]
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. [5] [8]
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. [8]
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. [8]
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. [8] 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. [8]
The FDA granted the application for elranatamab priority review, breakthrough therapy, and orphan drug designations; [8] and granted approval of Elrexfio to Pfizer Inc. [8]
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. [12] The applicant for this medicinal product is Pfizer Europe MA EEIG. [12]
Elranatamab was approved for medical use in the United States in August 2023, [5] [8] in the European Union in December 2023, [7] and in Canada in January 2024. [1]
Elranatamab is the international nonproprietary name. [13]
Elranatamab is sold under the brand name Elrexfio. [1] [5] [7]
This article incorporates public domain material from the United States Department of Health and Human Services