Europe clears new indication for Pfizer's Sutent; first approval for Sumavel DosePro in Denmark

The European Commission has approved global drugs behemoth Pfizer’s (NYSE: PFE) Sutent (sunitinib malate) for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumors (NET) with disease progression in adults.

The company notes that experience with Sutent as initial treatment is limited in this disease. Pancreatic NET is a rare cancer reported in two to four people per million annually worldwide. Sutent is the first targeted treatment to be cleared for this patient population in 25 years, it said.

In the USA, Sutent is already approved as a treatment for kidney cancer and for tumors of the stomach, esophagus and bowels that do not respond to other treatment. The drug generated global revenues of $771 million in the first nine months of this year. Pfizer is seeking additional approvals, but has reported unsuccessful trials with sunitinib over the last year in lung and prostate cancer (The Pharma Letters passim). Sutent is also approved for the treatment of unresectable well-differentiated advanced and/or metastatic pancreatic neuroendocrine carcinoma in the Philippines, Switzerland, Colombia and Korea. In addition, it is under regulatory review for this indication in several other countries.