Second drug receives FDA approval for advanced RCC

Feb 02, 2006

The FDA has approved sunitinib (Sutent), a tyrosine kinase inhibitor, for the treatment of advanced renal cell carcinoma.

The FDA has approved sunitinib (Sutent), a tyrosine kinase inhibitor, for the treatment of advanced renal cell carcinoma. The approval was based on the drug’s ability to reduce tumor size in patients with the disease. An overall response rate ranging from 26% to 37% was found in patients with metastatic disease whose tumors had progressed following cytokine-based therapy.

The most commonly reported drug-related side effects in studies included diarrhea, skin discoloration, mouth irritation, weakness, and altered taste.

Sunitinib’s FDA approval marks the second approval of a drug for treatment of advanced renal cell carcinoma in recent months. Sorafenib (Nexavar) was approved for this indication in late December.