ELREXFIO
ELREXFIO is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory multiple myeloma. It is specifically used for patients who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. This drug received accelerated approval based on response rate and durability of response, and its continued approval may be contingent upon verification of clinical benefit in confirmatory trials.
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.
Details
- Status
- Prescription
- First Approved
- 2023-08-14
- 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 Competitors
Pro3 other drugs also target BCMA. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (BCMA). Earlier expiry dates signal biosimilar/generic opportunities.
Drugs Similar to ELREXFIO
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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
ProIndications & Usage
FDA Label (PDF)ELREXFIO is indicated for the treatment of adult patients 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. This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies ] . Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). ELREXFIO is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T‑cell engager in...
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.