Pfizer's Sutent OKed by the EC for MRCC

World drug giant Pfizer says that Sutent (sunitinib malate) has received the European Commission's full marketing authorization for the treatment of advanced and/or metastatic renal cell carcinoma, a type of advanced kidney cancer. It is the first multiple receptor tyrosine kinase inhibitor to be approved in the Europe Union for first-line MRCC.

Sunitinib 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 the multicenter international study, supporting Sutent's approval, 750 patients received the drug or interferon-alfa, the current standard-of-care. Sutent patients had prolonged progression-free survival in first-line treatment for MRCC. They experienced 11-month median PFS - more than double the five-month median PFS observed with IFN-alfa. Sutent also demonstrated a five-fold higher objective response rate compared with IFN-alfa in first-line MRCC treatment (28% versus 5%).