Clinical Studies

The European Commission's full marketing authorization for Sutent in January 2007 was based on data from a large phase III mRCC trial2. In this multicenter international study, 750 patients received sunitinib malate or interferon-alfa (IFNα), the current standard of care.

Patients taking sunitinib malate had more than doubled prolonged progression-free survival (PFS) in first-line treatment for mRCC.

• Patients in the sunitinib malate arm experienced 11-month median PFS more than double the 5-month median PFS observed with IFNα.2

• Sunitinib malate demonstrated a 5-fold higher objective response rate (ORR) compared with IFNα in first-line mRCC treatment (31% vs. 6%).2

• Sunitinib malate is generally well tolerated with fewer discontinuations than IFNα. Fewer patients discontinued the medicine because of treatment-related adverse events (8% vs. 13%).2

Sunitinib malate's side effects in clinical studies for the treatment of mRCC were generally mild or moderate. The most common treatment-related adverse events of any grade were fatigue, gastrointestinal disorders such as diarrhea, nausea, stomatitis, dyspepsia, and vomiting; skin discoloration; dysgeusia; hypertension; and anorexia.2

The proportion of patients with treatment-related severe adverse events (grade 3 and 4) was relatively low in both groups (sunitinib malate vs. IFNα).2

In addition to its full authorization for the treatment of mRCC in the EU, sunitinib malate is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST) after failure of imatinib mesylate treatment due to resistance or intolerance.

Background on Sunitinib malate's full marketing authorization for mRCC

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Contact: Alison MacKenzie
alison@reynoldsmackenzie.com
20-703-14360
Reynolds-MacKenzie
22-Mar-2007