FDA panel backs drug for early-stage breast cancer
WASHINGTON - Government cancer experts say a drug from Roche has shown effectiveness as a new option to treat breast cancer before tumor-removing surgery.
The Food and Drug Administration panel voted 13-0, with one abstention, that the benefits of Perjeta as an initial treatment for breast cancer outweigh its risks. The recommendation is not binding, but could clear the way for the FDA to clear the drug as the first pharmaceutical option approved to shrink or eliminate cancerous tumors before surgery.
A study by Roche's Genentech unit showed women who received Perjeta as initial treatment were 18 percent more likely to be cancer-free after 12 weeks than women who received older drugs.
The FDA is considering granting Perjeta accelerated approval, a step reserved for promising drugs that have shown groundbreaking results.