WASHINGTON — The Food and Drug Administration has issued a positive review of a breast cancer drug from Roche that could soon become the first pharmaceutical option approved for treating early-stage disease before surgery.
In documents posted online, FDA scientists said women who received the drug Perjeta as initial treatment for breast cancer were more likely to be cancer-free at the time of surgery than women who received older drug combinations. Although the results come from midstage trials of the drug, FDA scientists recommended accelerating approval of the drug.
Perjeta was first approved last summer to treat women with a subtype of breast cancer that has already spread. But Roche’s Genentech unit is seeking approval to use the drug after diagnosis and before surgery to remove the tumor.
Surgery to remove tumors is the first step in treating virtually all forms of cancer. If approved, Perjeta would be the first cancer drug approved for use as a presurgical step.