Indications And Clinical Use
SUTENT (sunitinib malate) is indicated for:
- the treatment of gastrointestinal stromal tumour (GIST) after failure of imatinib mesylate treatment due to resistance or intolerance.
Approval of SUTENT is based on Time to Tumour Progression (TTP). Overall survival advantage could not be confirmed (see CLINICAL TRIALS section).
- the treatment of metastatic renal cell carcinoma (MRCC) of clear cell histology. Approval for MRCC is based on statistically significant progression free survival in patients with good performance status (ECOG 0-1). There was a trend for overall survival advantage (see CLINICAL TRIALS).
- the treatment of patients with unresectable locally advanced or metastatic, well- differentiated pancreatic neuroendocrine tumours (pancreatic NET), whose disease is progressive.
Approval for pancreatic NET is based on progression free survival in patients with good performance status (ECOG 0-1) (see CLINICAL TRIALS section).
The safety and efficacy of SUTENT in pediatric patients have not been established (see WARNINGS AND PRECAUTIONS, and TOXICOLOGY).
Geriatrics (> 65 years of age):
Of 825 GIST and MRCC patients who received SUTENT on clinical trials, 277 (34%) were 65 and over. In the Phase 3 pancreatic NET study, 22 (27%) patients who received SUTENT were 65 and over. No overall differences in safety or efficacy were observed between younger and older patients.