If Sutent is not covered on insurance for RCC is because Nexavar was approved based on Phase III data and it was approved with a valid clinical benefit endpoint: Progression Free Survival. Besides the FDA approved Nexavar with no conditions. Whereas, Sutent is approved based on two small phase II studies with only response data and with conditional approval (ie. pending or subject to verification in Phase III study results-conditional approval). Everyone in the cancer field knows that response data does not correlate with overall survival. Plus look at all the bolded precautions in the Sutent label below (courtesy of someone on this board):
Ventricular Dysfunction (LVEF), Hemorrhage/bleeding, cardiovascular deaths, Skin discoloration (drug for Mikael Jackson?), Seizures, hair color changes,fatal gastrointestinal complications ...on and on on on, on, on......where's the end???These poor cancer patients will die a horrible death ...Thanks to Sutent
Comapre this to Nexavar....
Why would anyone take Sutent for Renal cell cancer when the label says NO RANDOMIZED TRIALS??? "indicated for the treatment of advanced renal cell carcinoma. Approval for advanced renal cell carcinoma is based on partial response rates and duration of responses. There are no randomized trials of SUTENT demonstrating clinical benefit such as increased survival or improvement in disease-related symptoms in renal cell carcinoma."
No randomized trial for RCC and NO clinical benefit???? Bizarre!!!
"SUTENT is indicated for the treatment of advanced renal cell carcinoma. Approval for advanced renal cell carcinoma is based on partial response rates and duration of responses. There are no randomized trials of SUTENT demonstrating clinical benefit such as increased survival or improvement in disease-related symptoms in renal cell carcinoma."
Check the following headers in Sutent label..
Left Ventricular Dysfunction
"Tumor hemorrhages were observed as early as cycle 1 and as late as cycle 6"
"Serious, sometimes fatal gastrointestinal complications including gastrointestinal perforation, have occurred rarely in patients with intra-abdominal malignancies treated with SUTENT."
Skin Discoloration Sutent 33% Placebo 0%
Hair color changes Sutent 17% Placebo 0%
Hemorrhage/bleeding Sutent 26% Pacebo 1%
Check under...on and on and on it keeps going....Cardiovascular
Venous Thromboembolic Events
No overdose of SUTENT was reported in completed clinical studies. In non-clinical studies mortality was observed following as few as 5 daily doses of 500 mg/kg (3000 mg/m 2 ) in rats. At this dose, signs of toxicity included impaired muscle coordination, head shakes, hypoactivity, ocular discharge, piloerection and gastrointestinal distress. Mortality and similar signs of toxicity were observed at lower doses when administered for longer durations.
Diarrhea Sutent 55% Placebo 5%
Nausea Sutent 54% Placebo 2%
Mucositis/stomatitis 53% Placebo 4%