| 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 nameElrexfio, is amedication used for the treatment ofmultiple myeloma.[8][12] Elranatamab is a bispecificB-cell maturation antigen (BCMA)-directed CD3T-cell engager.[8][12][13][14] Elranatamab is given bysubcutaneous injection.[8][12]
The most common side effects includecytokine release syndrome,fatigue,injection site reaction,diarrhea,upper respiratory tract infection,musculoskeletal pain,pneumonia,decreased appetite,rash,cough,nausea, andpyrexia (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]
Elranatamab isindicated 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]
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 USFood and Drug Administration (FDA) prescribing information for elranatamab has aboxed warning for life-threatening or fatal cytokine release syndrome and neurologic toxicity, including immune effector cell-associated neurotoxicity.[12]
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/refractorymultiple myeloma who are refractory to at least oneproteasome inhibitor, oneimmunomodulatory 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 elranatamabpriority review,breakthrough therapy, andorphan drug designations;[12] and granted approval of Elrexfio toPfizer Inc.[12]
In October 2023, theCommittee for Medicinal Products for Human Use of theEuropean 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]
Elranatamab is theinternational nonproprietary name.[17]
Elranatamab is sold under the brand name Elrexfio.[4][8][11]
This article incorporates text from this source, which is in thepublic domain. This article incorporatespublic domain material from the United States Department of Health and Human Services
