Palifermin was approved on only one Phase 3 trial
Post# of 72440
Posted On: 10/05/2016 12:38:08 PM
Palifermin was approved on only one Phase 3 trial of ~300 patients. The primary endpoint was incidence of severe OM (Grade 3 or 4).
Palifermin - 63%
Placebo - 98%
So the effective rate is about 38%, not very impressive.
https://www.ncbi.nlm.nih.gov/pubmed/16390600
"In addition to a lower incidence of severe oral mucositis, patients receiving palifermin had almost one week less severe mucositis compared to those receiving placebo (10.4 days vs 3.7 days). Furthermore, palifermin-treated patients reported 60 percent less soreness of the mouth and throat, required lower doses of painkillers and less total parenteral nutrition use (11 percent versus 40 percent with placebo)."
http://www.amgen.com/media/news-releases/2003...-patients/
Palifermin - 63%
Placebo - 98%
So the effective rate is about 38%, not very impressive.
https://www.ncbi.nlm.nih.gov/pubmed/16390600
"In addition to a lower incidence of severe oral mucositis, patients receiving palifermin had almost one week less severe mucositis compared to those receiving placebo (10.4 days vs 3.7 days). Furthermore, palifermin-treated patients reported 60 percent less soreness of the mouth and throat, required lower doses of painkillers and less total parenteral nutrition use (11 percent versus 40 percent with placebo)."
http://www.amgen.com/media/news-releases/2003...-patients/
Quote:
Wonder what the effective rate is.
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