Drug updated on 4/16/2024
| Dosage Form | Injection (subcutaneous; 76 mg/1.9 mL [40 mg/mL] in a single-dose vial, 44 mg/1.1 mL [40 mg/mL] in a single-dose vial) |
| Drug Class | Bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engagers |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- 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.
Summary
- Elranatamab-bcmm (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.
- The study involved a Randomized Controlled Trial.
- Regarding efficacy, Elrexfio has shown promising results in the ongoing phase 2 MagnetisMM-3 study involving patients with relapsed or refractory multiple myeloma who had not received prior BCMA-directed therapy; it achieved an objective response rate (ORR) of 61.0% and complete response in 35.0% of cases.
- In terms of safety, common adverse events included infections, cytokine release syndrome (CRS), anemia, and neutropenia; however, switching to biweekly dosing reduced grade 3–4 adverse events from 58.6% to 46.6%, suggesting improved long-term safety without compromising efficacy.
- While direct comparison data were absent within the study reviewed, indirect comparisons suggest that Elrexfio's ORR and durability are competitive benchmarks within this advanced disease stage compared to similar treatments for multiple myeloma.
- The ability to switch to biweekly dosing provides important considerations for long-term treatment planning, potentially enhancing patient quality of life especially among individuals with relapsed or refractory multiple myeloma who have exhausted several lines of therapy - a notably difficult-to-treat population group where demonstrated efficacy becomes particularly compelling.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Elrexfio (elranatamab-bcmm) Prescribing Information. | 2023 | Pfizer Inc., New York, NY |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| Elranatamab in relapsed or refractory multiple myeloma: phase 2 MagnetisMM-3 trial results. | 123Subjects F: 45% M: 55% | 2023 | Nature Medicine |
Document Title
Sex Distribution:
F:45%
M:55%
123Subjects
Year:
2023
Source:Nature Medicine