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May 23, 2011

FDA Expands Sutent Label to Include Pancreatic Neuroendocrine Tumors

FDA Expands Sutent Label to Include Pancreatic Neuroendocrine Tumors

Sanction marks success after a slew of late-stage trial failures in other cancers. [© krishnacreations - Fotolia.com]

  • Pfizer’s Sutent® has been approved for the treatment of advanced pancreatic neuroendocrine tumors (NET) by the FDA. The anti-VEGF therapy may now be used in progressive, well-differentiated pancreatic NETs in patients with unresectable locally advanced or metastatic disease.

    The decision marks the second drug sanctioned in the U.S. for pancreatic NET since the beginning of May. Novartis’ Afinitor, an mTOR inhibitor, was given the go-ahead in the same indication on May 6.

    Sutent was also approved in Europe for pancreatic NET. In December 2010 the drug was sanctioned by the EC for unresectable or metastatic, well-differentiated pancreatic NET with disease progression in adults. It is also reportedly available in nine other countries for this indication.

    Pancreatic NET represents the third indication for Sutent. It was first approved by the FDA in 2006 for advanced kidney cancer and then later for imatinib-resistant or intolerant gastrointestinal stromal tumor (GIST). Revenue for Sutent in the first quarter of this year was $276 million compared to $259 million in the same period last year. The drug brought in almost $1.07 billion in the full-year 2010.

    Pfizer continues its label-expansion efforts with Sutent and is conducting a Phase III trial in renal cell cancer. Several prior attempts to broaden Sutent’s use failed. Since April 2009, Pfizer has reported unsuccessful late-stage trials in breast cancer, metastatic colorectal cancer, advanced non-small-cell lung cancer, and castration-resistant prostate cancer.

    FDA approval of Sutent in pancreatic NET was based on data from the SUN 1111 Phase III trial, which demonstrated that the drug provided a clinically significant improvement in progression-free survival (PFS) compared to placebo (10.2 versus 5.4 months of median PFS). Treatment with Sutent also yielded a statistically significant improvement in tumor response, with an objective response rate (ORR) of 9.3%. In addition, while overall survival (OS) was not mature at the time of final analysis, nine deaths were observed in patients enrolled in the Sutent arm versus 21 deaths in the placebo arm.


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