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Palifermin before only
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 receiving myeloablative chemotherapy and hematopoietic stem cell transplantation, Mucositis prevention in cancer patients undergoing high-dose chemotherapy or chemoradiation.
At a glance
| Generic name | Palifermin before only |
|---|---|
| Also known as | Kepivance |
| Sponsor | Swedish Orphan Biovitrum |
| Drug class | Fibroblast growth factor (FGF) analog |
| Target | FGFR2 (Fibroblast Growth Factor Receptor 2) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
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 and gastrointestinal mucosa damaged by chemotherapy or radiation, reducing the severity and duration of mucositis.
Approved indications
- Oral mucositis in patients receiving myeloablative chemotherapy and hematopoietic stem cell transplantation
- Mucositis prevention in cancer patients undergoing high-dose chemotherapy or chemoradiation
Common side effects
- Dysgeusia (taste alteration)
- Edema
- Erythema
- Fever
- Hyperplasia of oral tissues
Key clinical trials
- 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)
- Busulfan, Melphalan, and Fludarabine With Peri-transplant Palifermin, Followed by a T-Cell Depleted Hematopoietic Stem Cell Transplant From HLA Matched or Mismatched Related or Unrelated Donors in Patients With Advanced Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) (PHASE2)
- A Study of Palifermin for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer Receiving Postoperative Radiotherapy and Concurrent Chemotherapy (PHASE1, PHASE2)
- Study to Evaluate Palifermin in the Reduction of Dysphagia in Patients With Locally Advanced Non-Small Cell Lung Cancer (NSCLC) (PHASE2)
- A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Advanced Head and Neck Cancer (PHASE3)
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |