Pfizer's Sutent gets FDA approval for gastrointestinal and kidney cancer

The US Food and Drug Administration has approved global drugs giant Pfizer's Sutent (sunitinib), a new targeted anticancer treatment for patients with gastrointestinal stromal tumors (GIST), a rare stomach cancer, and advanced kidney cancer. This marks the first time the agency has approved a new oncology product for two indications simultaneously.

Sutent, which received an FDA priority review in October 2005 and was approved in less than six months, is a tyrosine kinase inhibitor working through multiple targets to deprive the tumor cells of the blood and nutrients needed to grow.

The drug will carry a price tag of about $37,713 per year patient cost, Pfizer has said. This is somewhat lower than the $51,996 that will be paid for a year of treatment with German drugmaker Bayer's newly, US-approved renal cancer drug Nexavar (sorafenib; Marketletter January 2 & 9). Analysts at Lehman Brothers have forecast peak annual global sales of Sutent at around $750.0 million. Bayer expects its drug to reach sales of $1.2 billion.