“U.S. regulators questioned data from Pfizer Inc. and Novartis AG on two potential therapies for a rare form of pancreatic cancer with limited treatment options, documents showed on Friday,” Esha Dey and Lisa Richwine report for Reuters.
“The companies are seeking approval to promote already approved cancer medicines for treating advanced pancreatic neuroendocrine tumors, an uncommon type of cancer that has afflicted Apple Inc. Chief Executive Steve Jobs,” Dey and Richwine report. “Food and Drug Administration staff, in a preliminary analysis, said Pfizer’s decision to end a study of the drug Sutent early may have led to an overestimation of its effectiveness. Agency reviewers also raised issues with Novartis’ findings on the benefits of its drug, Afinitor… Pfizer’s Sutent study was terminated well before a scheduled interim analysis that required 130 events of patients living without their disease progressing, FDA reviewers said.”
Dey and Richwine report, “Pfizer said the Sutent study was stopped early based on a recommendation from an independent data monitoring committee. The recommendation was based on prolonged progression-free survival reported in patients getting Sutent compared with a higher number of deaths and serious adverse events in those getting a placebo, the company said.”
“An FDA advisory panel is set to meet Tuesday to review data on Sutent and the Novartis drug. The FDA usually follows panel recommendations. Since the drugs already are on the market, doctors are free to prescribe them for pancreatic cancers. But the manufacturers need FDA approval to promote the medicines for that use,” Dey and Richwine report. “Pancreatic neuroendocrine tumors are rare and usually slower growing than other pancreatic cancers that kill within months after diagnosis. Both types have few treatment options.”
Read more in the full article here.
[Thanks to MacDailyNews Reader “Brawndo Drinker” for the heads up.]