SILVER SPRING, Maryland (Reuters) - A U.S. advisory panel on Tuesday backed the use of Pfizer Inc’s cancer drug Sutent to treat a rare type of pancreatic cancer that has very few treatment options.
While the U.S. Food and Drug Administration panel voted 8-2 in favor of Sutent, several panelists recommended further studies to clearly establish the drug’s efficacy in treating patients with pancreatic neuroendocrine tumors.
The backing came even though FDA staff said last Friday that an early end to a study of Sutent in pancreatic cancer may have led to an overestimation of its effectiveness.
The FDA also noted there was no significant improvement in the overall survival of patients, while a higher frequency of common side effects was recorded.
Earlier in the day, the panel unanimously recommended the approval of Novartis AG’s cancer drug Afinitor for use in the same, rare type of pancreatic cancer.
While a positive panel vote does not always lead to regulatory approval of a drug, the FDA usually follows panel recommendations.
The drug, also known as sunitinib, is already approved for advanced kidney cancer and gastrointestinal stromal tumors and brings in more than $1 billion in annual sales.
Pfizer has been trying to expand the use of Sutent, after it failed to prove its efficacy in breast and prostate cancer studies earlier and also faced a setback in liver cancer last year.
Pfizer shares closed down 1 percent at $20.46 on the New York Stock Exchange.
Reporting by Esha Dey; Editing by Richard Chang