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Pfizer's Sutent gets extra EC approval

Pfizer's Sutent has received European approval for a new indication in the treatment of progressive pancreatic Neuroendocrine tumours (NET)

Pfizer has announced that it has received approval from the European Commission (EC) for a new indicated use of Sutent (sunitinib malate) for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours (NET) with disease progression in adults. 

This, the first targeted therapy approved in Europe for the treatment of pancreatic NET, is based on results of a randomised phase III trial. Data from the trial showed that the time period that patients were free from disease progression or death more than doubled in those treated with Sutent compared with placebo.

"This approval represents a significant milestone in the management of pancreatic NET," said Dr Mace Rothenberg, senior vice president of clinical development and medical affairs, at Pfizer Oncology Business Unit.

"Sutent has been a standard of care for patients with advanced/metastatic renal cell carcinoma (RCC) and imatinib-refractory gastrointestinal stromal tumour (GIST) for several years, and we are proud that it is now a treatment option for patients in Europe with progressive pancreatic NET," Dr Rothenberg continued.

Pancreatic NET is a rare cancer reported in two to four people per million annually worldwide. However, this incidence appears to be rising and accounts for around 9 per cent of all neuroendocrine tumours. Sutent is the first treatment to be approved for patients with pancreatic NET in 25 years.

Dr Eric Raymond, principal investigator of the phase III study that led to the European approval of Sutent for pancreatic NET, said: "As the first anti-VEGF therapy to show a substantial clinical benefit in treating progressive pancreatic NET, Sutent represents a novel therapeutic approach for this difficult-to–treat disease." 

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.

2nd December 2010

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