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Dec 2 2010

Pfizer’s SUTENT Gets EU Approval For Pancreatic NETs

Pfizer’s SUTENT Gets European Approval For Pancreatic Neuroendocrine Tumors

Pfizer Inc. (PFE) Thursday said that the European Commission has approved SUTENT or sunitinib malate for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumors with disease progression in adults.

The company noted that the approval is based on results from a randomized, Phase 3 trial that demonstrated SUTENT more than doubled the time period that patients were free from disease progression or death.

The progression-free survival for SUTENT was 11.4 months compared to 5.5 months for placebo in 171 patients. While the overall survival data were not mature at the time of analysis, the overall survival favored the SUTENT arm compared with placebo.

SUTENT is an oral multi-kinase inhibitor 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.

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