ROLVEDON (eflapegrastim-xnst)
Rolvedon (eflapegrastim-xnst) is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients. It is used for individuals with non-myeloid malignancies who are receiving myelosuppressive anti-cancer drugs associated with a clinically significant risk of febrile neutropenia. The therapy is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
How ROLVEDON Works
Eflapegrastim-xnst is a recombinant human granulocyte growth factor that binds to G-CSF receptors on myeloid progenitor cells and neutrophils. This binding triggers specific signaling pathways that control the differentiation, proliferation, migration, and survival of these cells. By activating these pathways, the drug promotes the development and maintenance of the immune cells necessary to prevent infection.
Details
- Status
- Prescription
- First Approved
- 2022-09-09
- Routes
- SUBCUTANEOUS
- Dosage Forms
- INJECTABLE
ROLVEDON Approval History
What ROLVEDON Treats
2 indicationsROLVEDON is approved for 2 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Febrile Neutropenia
- Infection
ROLVEDON 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.
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.
Drugs Similar to ROLVEDON
3 of 20FDA-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.
ROLVEDON FDA Label Details
Indications & Usage
FDA Label (PDF)ROLVEDON is indicated for the treatment of Febrile Neutropenia; Infection.
Track ROLVEDON with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.