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Kepivance (Palifermin)
Palifermin is a recombinant human fibroblast growth factor 7 (FGF-7) that stimulates epithelial cell proliferation and differentiation to promote healing of damaged mucous membranes.
Palifermin is a recombinant human fibroblast growth factor 7 (FGF-7) that stimulates epithelial cell proliferation and differentiation to promote healing of damaged mucous membranes. Used for Oral mucositis in patients with hematologic malignancies receiving myeloablative chemotherapy followed by hematopoietic stem cell transplantation.
At a glance
| Generic name | Kepivance (Palifermin) |
|---|---|
| Sponsor | Swedish Orphan Biovitrum |
| Drug class | Fibroblast growth factor (FGF) receptor agonist |
| Target | FGFR2 (Fibroblast Growth Factor Receptor 2) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Mechanism of action
Palifermin binds to fibroblast growth factor receptor 2 (FGFR2) on epithelial cells, triggering signaling pathways that increase cell proliferation, differentiation, and migration. This accelerates the regeneration and repair of oral mucosa and gastrointestinal epithelium damaged by chemotherapy or radiation, reducing the severity and duration of mucositis.
Approved indications
- Oral mucositis in patients with hematologic malignancies receiving myeloablative chemotherapy followed by hematopoietic stem cell transplantation
Common side effects
- Dysgeusia (taste alteration)
- Edema
- Erythema
- Fever
- Hyperamylasemia
Key clinical trials
- Lentiviral Gene Transfer for Treatment of Children Older Than Two Years of Age With X-Linked Severe Combined Immunodeficiency (XSCID) (PHASE1, PHASE2)
- Base Editing Hematopoietic Stem Cell and T Cell Gene Therapy for CD40L-HyperIgM Syndrome: Single Patient Study (PHASE1, PHASE2)
- Base Editing for Mutation Repair in Hematopoietic Stem & Progenitor Cells for X-Linked Chronic Granulomatous Disease (PHASE1, PHASE2)
- A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation (PHASE2)
- Base-Edited Hematopoietic Stem/Progenitor Cell X-Linked Severe Combined Immunodeficiency Gene Therapy (PHASE1, PHASE2)
- Palifermin With Leuprolide Acetate for the Promotion of Immune Recovery Following Total Body Irradiation Based T-Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation (PHASE2)
- Human Lysozyme Goat Milk for the Prevention of Graft Versus Host Disease in Patients With Blood Cancer Undergoing a Donor Stem Cell Transplant (PHASE1)
- Study of Palifermin (Kepivance) in Persons Undergoing Unrelated Donor Allogeneic Hematopoietic Cell Transplantation (PHASE1, PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Kepivance (Palifermin) CI brief — competitive landscape report
- Kepivance (Palifermin) updates RSS · CI watch RSS
- Swedish Orphan Biovitrum portfolio CI