Overview
Elranatamab is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager. It is a humanized immunoglobulin 2-alanine kappa antibody derived from two monoclonal antibodies (mAbs), an anti-BCMA mAb and an anti-CD3 mAb, each of which contributes one heavy chain and one light chain to drug structure. The resulting 4-chain bispecific antibody is covalently linked via five inter-chain disulfide bonds. On August 14, 2023, the FDA granted accelerated approval to elranatamab for the treatment of multiple myeloma.
Indication
Elranatamab 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. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s).
Associated Conditions
- Refractory Multiple Myeloma
- Relapsed Multiple Myeloma
Research Report
Elranatamab (Elrexfio®): A Comprehensive Clinical and Pharmacological Monograph for the Treatment of Relapsed/Refractory Multiple Myeloma
Section 1: Executive Summary and Drug Profile
1.1. Overview
Elranatamab, marketed under the brand name Elrexfio®, represents a significant advancement in the field of hematologic oncology, specifically for the treatment of multiple myeloma (MM). It is a first-in-class, humanized, subcutaneously administered bispecific T-cell engager (BiTE) antibody developed by Pfizer.[1] This innovative immunotherapy is designed to provide a readily available, "off-the-shelf" therapeutic option for a patient population with a dire prognosis: adults with heavily pretreated, relapsed/refractory multiple myeloma (RRMM).[5] Elranatamab has received regulatory approval for patients who have exhausted at least four prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody, positioning it as a critical new agent in a therapeutic landscape characterized by sequential resistance and diminishing options.[1]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/30 | Phase 2 | Not yet recruiting | |||
2025/05/25 | Phase 1 | Not yet recruiting | |||
2025/05/16 | Phase 2 | Recruiting | |||
2025/04/27 | Phase 2 | Recruiting | |||
2025/04/17 | Phase 2 | Not yet recruiting | |||
2025/04/09 | Phase 3 | Recruiting | |||
2025/03/25 | Phase 1 | Not yet recruiting | David Avigan | ||
2025/03/03 | N/A | Recruiting | St. Olavs Hospital | ||
2025/02/18 | Phase 2 | Not yet recruiting | |||
2024/12/02 | Phase 2 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| U.S. Pharmaceuticals | 63539-252 | SUBCUTANEOUS | 44 mg in 1.1 mL | 7/31/2025 | |
| Pfizer Laboratories Div Pfizer Inc | 0069-2522 | SUBCUTANEOUS | 44 mg in 1.1 mL | 8/15/2023 | |
| Pfizer Laboratories Div Pfizer Inc | 0069-4494 | SUBCUTANEOUS | 76 mg in 1.9 mL | 8/15/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 12/7/2023 | ||
Authorised | 12/7/2023 | ||
Authorised | 12/7/2023 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| ELREXFIO SOLUTION FOR INJECTION 76 MG/1.9 ML | SIN17156P | INJECTION, SOLUTION | 76 mg/1.9 ml | 12/31/2024 | |
| ELREXFIO SOLUTION FOR INJECTION 44 MG/1.1 ML | SIN17155P | INJECTION, SOLUTION | 44 mg/1.1 ml | 12/31/2024 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| ELREXFIO elranatamab 44 mg/1.1 mL solution for injection vial | 408212 | Medicine | A | 6/28/2024 | |
| ELREXFIO elranatamab 76 mg/1.9 mL solution for injection vial | 408213 | Medicine | A | 6/28/2024 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| ELREXFIO 40 MG/ML SOLUCION INYECTABLE | 1231770001 | SOLUCIÓN INYECTABLE | Uso Hospitalario | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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