User:Noxoug1/elranatamab
| Clinical data | |
|---|---|
| Trade names | Elrexfio |
| Other names | elranatamab-bcmm |
| License data |
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| Routes of administration | Islet cell transplantation via intravenous infusion[1][2] |
| ATC code |
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| Legal status | |
| Legal status | |
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| KEGG | |
elranatamab, sold under the brand name Elrexfio, is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for adults with relapsed or refractory multiple myeloma.[4]
The primary mechanism of action of elranatamab is designed to bind to BCMA, which is highly expressed on the surface of multiple myeloma cells, and CD3 receptors found on the surface of T-cells, bridging them together and activating the T-cells to kill the myeloma cells. Elranatamab is administered subcutaneously.[4]
Elranatamab was approved for medical use in the United States in August 2023.[4]
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.[4]
Elranatamab is an investigational, off-the-shelf, humanized BCMA CD3-targeted BsAb. The binding affinity of elranatamab for BCMA and CD3 has been engineered to elicit potent T-cell-mediated anti-myeloma activity. [4]
Adverse effects[edit]
The most common adverse reactions include cytokine release syndrome (CRS), fatigue, injection site reaction, diarrhea, upper respiratory tract infection, musculoskeletal pain, pneumonia, decreased appetite, rash, cough, nausea, and pyrexia.[4]
History[edit]
The safety and effectiveness of elranatamab was evaluated in MagnetisMM-3 (NCT04649359), an open-label, single-arm, multi-center study that included patients with relapsed/refractory MM who are refractory to at least one proteasome inhibitor, one immunomodulatory drug, and one anti-CD38 antibody.[4][5]
Overall, the study consisted of 97 participants naïve to prior BCMA-directed therapy and who had previously received at least 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.[4]
The FDA granted approval of Elrexfio to Pfizer Inc.[4]
References[edit]
- ^ "Archived copy". Food and Drug Administration. Archived from the original on 9 December 2022. Retrieved 29 June 2023.
{{cite web}}: CS1 maint: archived copy as title (link) - ^ "Archived copy". Food and Drug Administration. Archived from the original on 19 May 2021. Retrieved 29 June 2023.
{{cite web}}: CS1 maint: archived copy as title (link) - ^ "View full prescribing information for Elrexfio" (PDF). Food and Drug Administration. Retrieved 14 August 2023.
- ^ a b c d e f g h i j "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.
- ^ "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 - Full Text View - ClinicalTrials.gov". clinicaltrials.gov. Retrieved 15 August 2023.
This article incorporates public domain material from the United States Department of Health and Human Services
