ELREXFIO (elranatamab)
ELREXFIO is indicated for the treatment of Multiple Myeloma.
How ELREXFIO Works
Elranatamab-bcmm is a bispecific antibody that simultaneously binds to BCMA on plasma cells and multiple myeloma cells and CD3 on T-cells. This dual binding action recruits and activates T-cells, leading to the release of proinflammatory cytokines. The resulting immune activation causes the direct cytolysis and destruction of the BCMA-expressing multiple myeloma cells.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2023-08-14
- Patent Cliff
- 2030
- Routes
- INJECTION
- Dosage Forms
- SOLUTION
ELREXFIO Approval History
What ELREXFIO Treats
1 indicationsELREXFIO is approved for 1 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Multiple Myeloma
ELREXFIO Boxed Warning
CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME • Cytokine Release Syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving ELREXFIO. Initiate treatment with ELREXFIO step-up dosing schedule to reduce the risk of CRS. Withhold ELREXFIO until CRS resolves or permanently discontinue based on severity [see Dosage and Administration (2.2 , 2.5 ), Warnings and Precautions (5.1) ] . • Neurologic to...
WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME • Cytokine Release Syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving ELREXFIO. Initiate treatment with ELREXFIO step-up dosing schedule to reduce the risk of CRS. Withhold ELREXFIO until CRS resolves or permanently discontinue based on severity [see Dosage and Administration (2.2 , 2.5 ), Warnings and Precautions (5.1) ] . • Neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), and serious and life-threatening reactions, can occur in patients receiving ELREXFIO. Monitor patients for signs and symptoms of neurologic toxicity, including ICANS, during treatment. Withhold ELREXFIO until the neurologic toxicity resolves or permanently discontinue based on severity [see Dosage and Administration (2.5) , Warnings and Precautions (5.2) ] . • Because of the risk of CRS and neurologic toxicity, including ICANS, ELREXFIO is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called ELREXFIO REMS [see Warnings and Precautions (5.3) ] . WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME See full prescribing information for complete boxed warning. • Cytokine Release Syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving ELREXFIO. Initiate treatment with ELREXFIO step-up dosing schedule to reduce risk of CRS. Withhold ELREXFIO until CRS resolves or permanently discontinue based on severity. ( 2.2 , 2.5 , 5.1 ) • Neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), and serious and life-threatening reactions, can occur in patients receiving ELREXFIO. Monitor patients for signs and symptoms of neurologic toxicity, including ICANS, during treatment. Withhold ELREXFIO until the neu
ELREXFIO Target & Pathway
ProTarget
A protein highly expressed on malignant plasma cells in multiple myeloma. BCMA-targeted therapies, including CAR-T cells and bispecific antibodies, can eliminate myeloma cells while sparing most normal immune cells.
ELREXFIO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in ELREXFIO's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ELREXFIO treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to ELREXFIO
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
30 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06152575 | C1071032 MAGNETISMM-32, 2023-507871-23-00 | Ph 3 | recruiting | MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide) |
| NCT06799026 | 24-439 | Ph 1 | recruiting | A Phase 1 Study of Vaccination With Dendritic Cell (DC)/Multiple Myeloma (MM) Fusions in Combination With Elranatamab in Relapsed or Refractory Multiple Myeloma |
| NCT06106945 | D7230C00001 2023-508590-89-00 | Ph 1, Ph 2 | recruiting | AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Multiple Myeloma |
| NCT06215118 | C1071030 MagnetisMM-30 | Ph 1 | recruiting | A Study to Learn About the Effects of the Combination of Elranatamab (PF-06863135) and Iberdomide in Patients With Relapsed or Refractory Multiple Myeloma (MagnetisMM-30) |
| NCT06057402 MagnetisMM15 | C1071015 2023-505200-33-00 | Ph 4 | recruiting | Elranatamab Post Trial Access Study for Participants With Multiple Myeloma (MM) |
| NCT05623020 MagnetisMM-6 | C1071006 MAGNETISMM-6, 2024-514139-50-00 | Ph 3 | recruiting | A Study to Learn About the Effects of the Combination of Elranatamab, Daratumumab and Lenalidomide Compared With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Transplant |
| NCT05020236 MAGNETISMM-5 | C1071005 MAGNETISMM-5, 2023-509208-14-00 | Ph 3 | recruiting | A Study to Learn About the Study Medicine Elranatamab Alone and With Daratumumab in People With Multiple Myeloma Who Have Received Other Treatments |
| NCT05927571 | GO43979 2023-504657-13-00 | Ph 1 | recruiting | A Study Evaluating the Safety, Pharmacokinetics, and Activity of the Combination of Cevostamab and Elranatamab in Participants With Relapsed or Refractory Multiple Myeloma (R/R MM) |
| NCT06974786 FASTER | MM 195 | Ph 2 | recruiting | Frontline T-cell Engager vs Autologous Stem Cell Transplant (ASCT) and Measurable Residual Disease (MRD)-Guided Sequential Intensification thERapy in Multiple Myeloma |
| NCT07280013 | CFT7455-1102 | Ph 1 | recruiting | A Study to Learn About the Effects of Cemsidomide in Combination With Elranatamab in Relapsed/Refractory Multiple Myeloma Subjects |
| NCT05317416 MagnetisMM-7 | C1071007 MagnetisMM-7, 2023-508897-27-00 | Ph 3 | active not recruiting | Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant |
| NCT07382739 | 2025-1557 NCI-2026-00668 | Ph 2 | recruiting | A Phase 2 Study of Radiotherapy-induced Immune Priming to Enhance Elranatamab (Elra) in Relapsed Refractory Multiple Myeloma (RRMM) With Extramedullary Disease (EMD) and Paramedullary Disease (PMD) "PRIME-EMD-PMD" |
| NCT05675449 MagnetisMM-20 | C1071020 MAGNETISMM-20 | Ph 1 | active not recruiting | A Clinical Trial of Four Medicines (Elranatamab Plus Carfilzomib and Dexamethasone or Maplirpacept) in People With Relapsed Refractory Multiple Myeloma |
| NCT06918002 ElLen | IFM 2025-01 2024-516418-39-00 | Ph 3 | recruiting | Elranatamab/Lenalidomide Consolidation and/or Elranatamab Maintenance Versus Standard of Care After D-VRd Induction in Transplant-eligible NDMM Patients |
| NCT06138275 | 23-402 | Ph 2 | recruiting | Elranatamab in R/R Multiple Myeloma |
| NCT06832865 | 24-727 | Ph 2 | recruiting | ELISA in Relapsed/Refractory MM |
| NCT06569147 | 24-290 | Ph 1, Ph 2 | recruiting | Elranatamab in Patients With Relapsed or Refractory AL Amyloidosis |
| NCT06711705 | 810312 | Ph 2 | recruiting | Elranatamab in Relapsed/Refractory Multiple Myeloma |
| NCT06207799 | 2023-0448 NCI-2024-00110 | Ph 2 | recruiting | Pre-transplant Purging and Post-transplant MRD-guided Maintenance Therapy With Elranatamab in Patients With High-risk Multiple Myeloma |
| NCT06121843 | CA088-1005 | Ph 1 | recruiting | A Study to Evaluate the Safety, Effectiveness and Tolerable Dose of Arlocabtagene Autoleucel (BMS-986393) in Novel Combinations in Participants With Relapsed and/or Refractory Multiple Myeloma |
| NCT06015542 ERICA | ERICA | Ph 2 | recruiting | Self-administration of Subcutaneous Elranatamab in the Patients' Homes. |
| NCT05014412 MagnetisMM-9 results posted | C1071009 MagnetisMM-9 | Ph 2 | completed | A Study to Learn About the Study Medicine (Elranatamab) in Participants With Multiple Myeloma That Has Come Back After Responding to Treatment or Has Not Responded to Treatment |
| NCT06988488 | CA057-1040 2025-522090-11, U1111-1317-4901 | Ph 1, Ph 2 | recruiting | A Study to Determine the Recommended Dose and Schedule, and Evaluate the Safety and Preliminary Efficacy of Mezigdomide in Combination With Elranatamab in Participants With Relapsed and/or Refractory Multiple Myeloma |
| NCT05228470 results posted | C1071008 NCT05228470 | Ph 2 | completed | A Study of Elranatamab (PF-06863135) in Chinese Participants With Refractory Multiple Myeloma. |
| NCT04068597 | CCS1477-02 | Ph 1, Ph 2 | recruiting | Study to Evaluate CCS1477 (Inobrodib) in Haematological Malignancies |
| NCT06947083 | MCC-23564 | Ph 2 | recruiting | Elranatamab Post Cilta-cel in Patients With Clinical High Risk Relapsed Myeloma |
| NCT06645678 MELT-MM | H-2410-028-1576 | Ph 1, Ph 2 | recruiting | Mezigdomide and Elranatamab for Relapsed and/or Refractory Multiple Myeloma |
| NCT06997081 | 20250076 | Ph 2 | recruiting | ERd Combination Treatment in Newly Diagnosed Multiple Myeloma |
| NCT06931704 IFM 2024_06 | RC23_0603 | Ph 2 | not yet recruiting | Comparison of Elranatamab and Lenalidomide Versus Daratumumab and Lenalidomide as Post-transplant Maintenance Therapy in Patients With Newly Diagnosed Myeloma (ElMMA) |
| NCT06183489 ERASMM | EMN34/2023-505775-70-00 | Ph 2 | recruiting | Use of Elranatamab in Patients With High-risk Smoldering Multiple Myeloma |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ELREXFIO FDA Label Details
Indications & Usage
FDA Label (PDF)ELREXFIO is indicated for the treatment of Multiple Myeloma.
WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME • Cytokine Release Syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving ELREXFIO. Initiate treatment with ELREXFIO step-up dosing sche...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment