Is it approved for solid tumors or general chemotherapy mucositis?

No. Its approved indication is limited to hematologic malignancies with stem cell transplant; use in solid tumors has been studied but is not the approved setting.

Why does the timing around chemotherapy matter so much?

Palifermin must not be given within 24 hours before, during, or after myelotoxic chemotherapy, because overlapping doses can increase mucositis severity rather than reduce it.

What are the common side effects?

Skin rash and redness, mouth or tongue thickening and discoloration, and altered taste are the most frequently reported effects.

As a short intravenous course, typically three daily doses before conditioning and three after stem cell infusion, administered by the transplant care team.

FDA-approved medicineaka Kepivance, recombinant human KGF, FGF-7

Palifermin — Complete Research Guide (2026)

Last updated 2026-07-31

TL;DR

Recombinant human keratinocyte growth factor, FDA-approved to reduce severe oral mucositis in blood-cancer patients undergoing stem-cell transplant.

What is Palifermin?

Palifermin (brand name Kepivance) is a recombinant human keratinocyte growth factor (KGF, also called FGF-7). It is FDA-approved to decrease the incidence and duration of severe oral mucositis in patients with hematologic malignancies receiving myelotoxic therapy that requires hematopoietic stem cell support.

Evidence is strong and human for this indication, anchored by the pivotal Spielberger 2004 NEJM randomized trial.

How does Palifermin work?

Palifermin binds the keratinocyte growth factor receptor on epithelial cells, stimulating proliferation, differentiation, and cytoprotection of the mucosal lining so it better withstands chemotherapy- and radiation-induced injury of the mouth and gastrointestinal tract.

What does the research say about Palifermin?

Palifermin significantly reduced the incidence and duration of severe (WHO grade 3-4) oral mucositis after total-body irradiation plus high-dose chemotherapy and autologous stem cell transplantation. ^[1]
A meta-analysis found palifermin reduced severe oral mucositis rates across pooled trials, supporting its mucosal-protective effect. ^[2]
Pediatric cancer mucositis guidelines recommend palifermin for defined high-dose conditioning and transplant settings. ^[3]

Clinical research & studies

The references below are the primary sources cited throughout this guide. Each links directly to PubMed or the regulator. Where evidence is preclinical (animal or in-vitro), that is stated rather than implied.

[1] Palifermin for oral mucositis after intensive therapy for hematologic cancers — Spielberger R et al., The New England Journal of Medicine 2004. (Phase 3 randomized, double-blind, placebo-controlled trial)
[2] A meta-analysis of palifermin efficacy for the management of oral mucositis in patients with solid tumours and haematological malignancy — Coutsouvelis J et al., Critical Reviews in Oncology/Hematology 2022. (Systematic review and meta-analysis)
[3] Clinical practice guideline for the prevention of oral and oropharyngeal mucositis in paediatric cancer and haematopoietic stem cell transplantation patients — Patel P et al., European Journal of Cancer 2021. (Evidence-based clinical practice guideline)
[4] Keratinocyte growth factor in focus: A comprehensive review from structural and functional aspects to therapeutic applications — Sadeghi S et al., International Journal of Biological Macromolecules 2021. (Narrative review)
[5] Systematic review of cytokines and growth factors for the management of oral mucositis in cancer patients — Raber-Durlacher JE et al., Supportive Care in Cancer 2013. (Systematic review)

Dosing context

This is not medical advice or a usage recommendation. Dosing figures are reported research context only, cited from the published literature.

In FDA labeling it is given as a short intravenous course of 60 micrograms/kg/day for three consecutive days before conditioning therapy and three consecutive days after stem cell infusion, with the pre- and post-transplant doses separated from chemotherapy by at least 24 hours.

This is background context only and not directions for use; dosing and timing are managed by the transplant/oncology team.

Side effects & safety profile

The most common adverse effects are skin reactions (rash, erythema, pruritus), mouth and tongue changes such as thickening or discoloration, and taste alteration (dysgeusia).

Because KGF receptors are present on epithelial tumors, palifermin is used only in the approved hematologic-malignancy setting, and dosing is timed to avoid overlap with chemotherapy: it should NOT be given within 24 hours before, during, or after myelotoxic chemotherapy, as concurrent administration can worsen mucositis severity and duration.

It is a prescription hospital medicine given under oncology supervision.

Stacking & combinations

It is a supportive-care agent administered within a defined transplant conditioning schedule and is not a compound for elective stacking; its timing relative to chemotherapy is strictly controlled by clinicians.

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Frequently asked questions

It is FDA-approved to reduce the incidence and duration of severe oral mucositis in patients with blood cancers undergoing myelotoxic therapy that needs stem cell support.

References

[1] Palifermin for oral mucositis after intensive therapy for hematologic cancers — Spielberger R et al., The New England Journal of Medicine 2004. PMID: 15602019. View sourceStudy: Phase 3 randomized, double-blind, placebo-controlled trialPalifermin significantly lowered the incidence and duration of severe oral mucositis in autologous stem cell transplant patients.
[2] A meta-analysis of palifermin efficacy for the management of oral mucositis in patients with solid tumours and haematological malignancy — Coutsouvelis J et al., Critical Reviews in Oncology/Hematology 2022. PMID: 35101586. View sourceStudy: Systematic review and meta-analysisPooled data showed palifermin reduces the risk of severe oral mucositis across treatment settings.
[3] Clinical practice guideline for the prevention of oral and oropharyngeal mucositis in paediatric cancer and haematopoietic stem cell transplantation patients — Patel P et al., European Journal of Cancer 2021. PMID: 34252760. View sourceStudy: Evidence-based clinical practice guidelineRecommends palifermin for specific high-dose conditioning and transplant regimens to prevent mucositis.
[4] Keratinocyte growth factor in focus: A comprehensive review from structural and functional aspects to therapeutic applications — Sadeghi S et al., International Journal of Biological Macromolecules 2021. PMID: 34606789. View sourceStudy: Narrative reviewReviews KGF biology and palifermin as its recombinant therapeutic form, including mucosal protection.
[5] Systematic review of cytokines and growth factors for the management of oral mucositis in cancer patients — Raber-Durlacher JE et al., Supportive Care in Cancer 2013. PMID: 22987094. View sourceStudy: Systematic reviewIdentifies palifermin as the growth factor with the strongest evidence for preventing severe oral mucositis in transplant patients.

This article is for educational and research purposes only. Peptides discussed here are not approved for human consumption by the FDA, EMA, or equivalent regulators outside of specific clinical contexts. Always consult a licensed medical professional before any therapeutic use.