{"entity":{"id":"palifermin","kind":"drug","name":"Palifermin","aka":["Recombinant keratinocyte growth factor","rHuKGF"],"tldr":"Palifermin (Kepivance) is a growth factor injected for three days before and after high-dose chemotherapy and stem cell rescue to reduce the severe mouth ulcers (mucositis) that this treatment causes in people with blood cancers.","summary":"Palifermin was approved by the FDA in December 2004 to decrease the incidence and duration of severe oral mucositis in patients with haematological malignancies receiving myelotoxic therapy with autologous stem cell support, when the regimen is expected to cause WHO grade 3 or worse mucositis in most patients; in the pivotal randomised trial of 212 patients receiving total body irradiation-based conditioning, grade 3 to 4 mucositis fell from 98% to 63% and its duration from 9 to 3 days. The EU authorised Kepivance in 2005. Its safety in non-haematological malignancies is not established because KGF receptors are present on many epithelial tumours, and it is not given within 24 hours of chemotherapy. Rash, tongue thickening and taste change are the usual effects. Marketed by Sobi.","status":"approved","asOf":"2026-09-10","wikipedia":"https://en.wikipedia.org/wiki/Palifermin","links":[{"label":"US label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=palifermin"},{"label":"NCI drug page","url":"https://www.cancer.gov/about-cancer/treatment/drugs/palifermin"},{"label":"EPAR","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/kepivance"}],"tags":["nci-list","supportive"],"related":[],"cancers":["multiple-myeloma","dlbcl","hodgkin-lymphoma"],"sections":[],"technologies":["autologous-stem-cell-transplant"],"targets":[],"drugs":[],"companies":["sobi"],"institutions":[],"pathways":[],"terms":[],"trials":["nct00434161","nct00101582","nct00109031"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Kepivance","modality":"Recombinant human keratinocyte growth factor","supportive":true,"mechanism":"Truncated recombinant KGF (FGF7) that binds the KGF receptor (FGFR2b) on epithelial cells of the mouth and gut, stimulating proliferation, differentiation and cytoprotection of the mucosa.","approvals":[{"region":"US","year":2004,"indication":"Reduction of severe oral mucositis in haematological malignancies with myelotoxic therapy and autologous stem cell support"},{"region":"EU","year":2005,"indication":"Same (Kepivance)"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/palifermin/","neighbours":{"cancer":[{"id":"dlbcl","kind":"cancer","name":"Diffuse large B-cell lymphoma","route":"/cancers/dlbcl/"},{"id":"hodgkin-lymphoma","kind":"cancer","name":"Hodgkin lymphoma","route":"/cancers/hodgkin-lymphoma/"},{"id":"multiple-myeloma","kind":"cancer","name":"Multiple myeloma","route":"/cancers/multiple-myeloma/"}],"technology":[{"id":"autologous-stem-cell-transplant","kind":"technology","name":"Autologous stem cell transplant (high-dose therapy)","route":"/technologies/autologous-stem-cell-transplant/"}],"company":[{"id":"sobi","kind":"company","name":"Sobi (Swedish Orphan Biovitrum)","route":"/companies/sobi/"}],"trial":[{"id":"nct00434161","kind":"trial","name":"A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Multiple Myeloma","route":"/trials/nct00434161/"},{"id":"nct00101582","kind":"trial","name":"Palifermin for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer","route":"/trials/nct00101582/"},{"id":"nct00109031","kind":"trial","name":"Palifermin for the Reduction of Oral Mucositis in Single-dose Evaluation (PROMISE)","route":"/trials/nct00109031/"}],"target":[{"id":"fgf7","kind":"target","name":"FGF7","route":"/targets/fgf7/"}]}}