KEPIVANCE
Kepivance (palifermin) is a mucocutaneous epithelial human growth factor indicated to reduce the incidence and duration of severe oral mucositis. It is used as supportive care for patients with hematologic malignancies undergoing myelotoxic therapy in the setting of autologous hematopoietic stem cell support. The drug is specifically intended for use with preparative regimens predicted to result in WHO Grade 3 or higher mucositis in the majority of patients.
How KEPIVANCE Works
Palifermin is a keratinocyte growth factor (KGF) that binds to KGF receptors found on epithelial cells in various tissues, including the tongue, buccal mucosa, and gastrointestinal tract. This binding stimulates the proliferation, differentiation, and migration of epithelial cells, which increases the thickness of the mucosal lining. By promoting these cellular processes, the drug helps protect against and repair tissue injury caused by chemotherapy and radiation.
Details
- Status
- Prescription
- First Approved
- 2004-12-15
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
KEPIVANCE Approval History
What KEPIVANCE Treats
2 indicationsKEPIVANCE is approved for 2 conditions since its original approval in 2004. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Oral Mucositis
- Hematologic Malignancies
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.
KEPIVANCE FDA Label Details
ProIndications & Usage
FDA Label (PDF)Kepivance is a mucocutaneous epithelial human growth factor indicated to decrease the incidence and duration of severe oral mucositis in patients with hematologic malignancies receiving myelotoxic therapy in the setting of autologous hematopoietic stem cell support. Kepivance is indicated as supportive care for preparative regimens predicted to result in ≥ WHO Grade 3 mucositis in the majority of patients. Limitations of Use The safety and efficacy of Kepivance have not been established in patients with non-hematologic malignancies Kepivance was not effective in decreasing the incidence of sev...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.