ROLVEDON
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
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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
ProIndications & Usage
FDA Label (PDF)Rolvedon is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. Limitations of Use Rolvedon is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. Rolvedon is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving my...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.