Sanction allows use of the drug to treat patients with pancreatic neuroendocrine tumors.

Pfizer’s Sutent gained approval from the European Commission for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumors with disease progression in adults. The positive news comes after a slew of failed attempts to expand the drug’s label.

Sutent, an oral multikinase inhibitor, was previously approved for the treatment of advanced/metastatic renal cell carcinoma and unresectable and/or metastatic malignant gastrointestinal stromal tumor after failure of imatinib mesilate treatment due to resistance or intolerance.

It works by blocking multiple molecular targets implicated in the growth, proliferation, and spread of cancer, according to Pfizer. Two important Sutent targets, vascular endothelial growth factor receptor and platelet-derived growth factor receptor, are expressed by many types of solid tumors and are thought to play a crucial role in angiogenesis.

Today’s sanction in pancreatic neuroendocrine tumors is based on results from a randomized, Phase III trial conducted in 171 patients. It demonstrated that Sutent more than doubled the time period that patients were free from disease progression or death. The progression-free survival (PFS) for Sutent-treated patients was 11.4 months versus 5.5 months for those given placebo. Additionally, while the overall survival data was not mature at the time of analysis, the overall survival favored the Sutent arm, Pfizer notes.

Over the last 18 months Pfizer has reported a number of unsuccessful late-stage trials with Sutent. In April 2009, the company said that the drug did not prove itself in the treatment of breast cancer as a single agent compared to capecitabine in patients who failed standard treatment nor along with paclitaxel versus bevacizumab plus paclitaxel as a first-line treatment.

In July 2009, Pfizer stopped testing Sutent plus Folfiri versus Folfiri alone as a first-line treatment of metastatic colorectal cancer. In March of this year Pfizer stopped two Sutent trials in advanced Her-2 negative breast cancer. These studies were assessing Sutent in combination with docetaxel as a first-line treatment and Sutent plus capecitabine in previously treated advanced breast cancer patients.

In August the firm said that combining Sutent with erlotinib as a therapy for advanced non-small-cell lung cancer (NSCLC) did not improve overall survival, the primary endpoint of the trial. More bad news followed a month later when Pfizer reported that the drug also did not improve overall survival in advanced castration-resistant prostate cancer.

Pfizer’s only success over the past year or so in expanding Sutent’s label came in June 2009. It reported that in a Phase III study, patients with advanced pancreatic islet cell tumors treated with the compound had a median PFS of 11.1 months compared to those on placebo who had a PFS of 5.5 months.

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