Tomorrow, a panel of outside experts will decide the fate of Pfizer's
Pfizer's Inlyta outperformed Onyx Pharmaceuticals
Since Sutent is the primary first-line treatment for patients in the U.S., the FDA is concerned that most patients might get the less-impressive result. The outside experts will end up spending a lot of time on this one issue and whether the smaller benefit justifies the risks of the drug.
I'm not sure how big of an issue this really is; the agency has seen these subset issues before. It didn't put any restrictions on Human Genome Sciences
That seems fair. If the agency is going to argue -- rightfully in my opinion -- that subgroup analysis can't be used to support marketing applications, why should it be used to reject them?
While the results might not keep Inlyta off the market, they could limit its use. Doctors who use Sutent first might not bother with Inlyta, given the data. Adding to the marketing worries, AVEO Pharmaceuticals
Pfizer investors won't have to wait too long to find out whether the FDA takes the advisory panel's advice and whether doctors will actually prescribe Inlyta; the PDUFA date for Pfizer's drug is March 13.