Pfizer Inc said today that Sutent? (sunitinib malate) has received the European Commission?s full marketing authorization for the treatment of advanced and/or metastatic renal cell carcinoma (MRCC), a type of advanced kidney cancer. It is the first multiple receptor tyrosine kinase inhibitor to be approved in the EU for first-line use in MRCC.
Sunitinib malate is an oral therapy belonging to a new class of dual-action multi-targeted drugs that attack cancer by inhibiting tumor growth and starving the tumor of blood, thereby reducing its ability to continue to divide and grow.
The European Commission?s full marketing authorization is based on data from a large phase III MRCC trial. In this multicenter international study, 750 patients received sunitinib malate or interferon-alfa (IFNa), the current standard of care.