Pfizer receives European approval for Sutent

Pfizer has revealed that its Sutent (sunitinib malate) drug is now approved by the European Commission.

Developed for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours (NET) in adults, the product received approval based on new phase III trial results.

A recent clinical study demonstrated that Sutent more than doubled the time period that pancreatic NET patients were free from disease progression or death.

According to Pfizer, the drug is the first new treatment to be approved for patients with pancreatic NET in 25 years.

Dr Mace Rothenberg, senior vice-president of clinical development and medical affairs at Pfizer's Oncology Business Unit, described the European decision as "a significant milestone in the management of pancreatic NET".

Sutent was also endorsed by Dr Eric Raymond, principal investigator of the pivotal phase III study, who said it provides a "novel therapeutic approach for this difficult-to–treat disease".

Last month, Pfizer announced it had submitted a marketing authorisation application to the European Medicines Agency for taliglucerase alfa.