Pfizer has been boosted by the news that regulators in Europe have granted an additional approval for its cancer drug Sutent.
Specifically, the European Commission has approved Sutent (sunitinib) for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours with disease progression in adults. This is a rare cancer reported in two to four people per million annually worldwide and Sutent is the first treatment to be approved for pancreatic NET in 25 years.
The approval is based on results from a Phase III trial that demonstrated Sutent more than doubled the time period patients were free from disease progression or death. The progression-free survival for the drug was 11.4 months versus 5.5 months for placebo in 171 patients.
Lead investigator of the trial, Eric Raymond of the University Department of Medical Oncology Bichat-Beaujon, Clichy, France, noted that as the first anti-vascular endothelial growth factor therapy to show a substantial clinical benefit in treating the aforementioned disease, "Sutent represents a novel therapeutic approach for this difficult-to–treat disease". Pfizer noted that regulatory applications in this indication are under review in several other countries and is already approved for pancreatic NET in the Philippines, Switzerland, Colombia and Korea.
The drug has been approved for advanced renal cell carcinoma and Glivec (imatinib)-refractory gastrointestinal stromal tumour for several years, and had third-quarter sales of $257 million, up 4%.