This follows the US launch in March as the first therapy for patients with RCC after failure of treatment with sunitinib or sorafenib. |
The drug, sunitinib, is sold under the name Sutent and targets pathways that cause certain cancers to grow. |
The recommended dose of sunitinib is 50 mg daily, in cycles: four weeks on, two weeks off treatment. |
Safety studies were conducted to evaluate the effects of sunitinib on the cardiovascular, respiratory and central nervous system in animals. |
Sutent is contraindicated in patients with hypersensitivity to sunitinib malate or to any other component of Sutent. |
Only rats demonstrated non-linear kinetics, and female rats had a higher systemic exposure to sunitinib compared to male rats. |