FYLNETRA
FYLNETRA is a leukocyte growth factor indicated to decrease the incidence of infection, manifested as febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs. It is also approved to increase survival in patients acutely exposed to myelosuppressive doses of radiation, a condition known as Hematopoietic Subsyndrome of Acute Radiation Syndrome. This medication is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
How FYLNETRA Works
FYLNETRA is a colony-stimulating factor that acts on hematopoietic cells by binding to specific cell surface receptors. This binding process stimulates the proliferation, differentiation, and commitment of these cells. Additionally, the drug triggers end cell functional activation to support the production and activity of white blood cells.
Details
- Status
- Prescription
- First Approved
- 2022-05-26
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
FYLNETRA Approval History
What FYLNETRA Treats
2 indicationsFYLNETRA is approved for 2 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Febrile Neutropenia
- Acute Radiation Syndrome
FYLNETRA is a lower-cost alternative to Neulasta with no clinically meaningful differences. Requires prescriber approval to substitute.
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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.
FYLNETRA FDA Label Details
ProIndications & Usage
FDA Label (PDF)FYLNETRA is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome). Limitations of Use FYLNETRA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.1 Patients with Canc...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.