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Pfizer's Sutent wins new FDA approval

Pfizer's cancer drug Sutent has received US Food and Drug Administration approval for the additional indication of the treatment of pancreatic neuroendocrine tumours in certain patients

Pfizer's marketed cancer drug Sutent (sunitinib malate) has received US Food and Drug Administration (FDA) approval for the additional indication of the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (NET) in patients with unresectable locally advanced or metastatic disease.

Pancreatic NET is a rare, slow-growing cancer reported in two to four people per million worldwide. There are fewer than 1,000 new cases in the US each year, according to the FDA.

Sutent was originally approved by the FDA in 2006 for treatment of patients with advanced kidney cancer and imatinib-resistant or intolerant gastrointestinal stromal tumour (GIST).

The pancreatic NET approval was based on data from an international phase III trial that enroled 171 patients. Results showed that the drug provided a clinically significant improvement in progression-free survival (PFS) in patients with unresectable pancreatic NET compared to placebo, which was the primary endpoint of the study. The active drug delivered 10.2 months of PFS, compared to 5.4 months seen with the placebo.

Sutent is an oral multi-kinase inhibitor that works by blocking multiple molecular targets involved in the growth of cancer. "Pancreatic NET is a highly vascular tumour, and as the first anti-VEGF therapy approved for this disease, Sutent represents a treatment that attacks a key component of tumour growth," said Dr Eric Raymond, professor of medical oncology and head of University Department of Medical Oncology (Service Inter Hospitalier de Cancerologie) Bichat-Beaujon, Clichy, France, who served as a principal investigator on the phase III trial.

Pfizer received approval from the European Commission (EC) for Sutent for the pancreatic NET indication late last year. In the US, the FDA's approval of the new indication for Sutent follows the agency's approval of Novartis' Afinitor (everolimus) for the same use earlier this month. The Novartis drug beat out the Pfizer drug by a brief margin of time to become the first new treatment approved for the indication in about 30 years.

Sutent is also approved in Colombia, Korea, the Philippines and Switzerland for the treatment of unresectable, well-differentiated advanced and/or metastatic pancreatic neuroendocrine carcinoma. The drug is also under regulatory review for this indication in several other countries.

23rd May 2011

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