FDA's expert advisors gave two thumbs up yesterday, one for Pfizer ($PFE) and one for Novartis ($NVS). The companies' cancer drugs Sutent and Afinitor won backing from the panel as treatments for a rare type of pancreatic cancer. FDA usually follows its expert panels' advice, but not always; a final decision is expected by the end of June, Novartis said.
The panel gave Novartis' Afinitor its unanimous approval, despite some serious side effects, saying that the potential benefits outweigh the risks, Reuters reports. Pfizer's Sutent got an 8-2 recommendation, for tumors that can't be treated with surgery, the Wall Street Journal notes. The two members who voted "no" said they felt that clinical trial data wasn't strong enough to support its use, because the study was stopped early and had fewer patients than planned.
The potential new use isn't expected to add a whole lot to either drug's sales, because there are relatively few cases of this type of cancer. Plus, both meds are already approved for kidney cancer, so they can be prescribed off label for other cancers. "Pancreatic neuroendocrine tumor is a relatively rare cancer representing about $100 million of peak sales potential, less than one percent to Novartis' core earnings per share," Deutsche Bank analyst Tim Race told Reuters.
- check out the Los Angeles Times story
- get the news from Reuters
- see the WSJ piece