FDA review backs breast cancer drug
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 mid-stage trials of the drug, FDA scientists recommended accelerating approval of the drug.
That step is reserved for groundbreaking drugs to treat life-threatening diseases. Roche's Genentech unit is now seeking approval to use the drug at a much earlier stage of the disease: after diagnosis and before surgery to remove the tumor.
If approved, Perjeta would be the first cancer drug approved for use as a pre-surgical step.
The FDA is scheduled to make a decision on whether to approve Perjeta for early-stage breast cancer by Oct. 31.