Roche breast cancer drug gets expanded U.S. pre-surgery approval
Sept 30 (Reuters) - U.S. health regulators expanded the approval of Roche Holding AG's breast cancer drug Perjeta and will now allow its use to help shrink tumors prior to surgery, the Food and Drug Administration said on Monday.
The decision followed a 13-0 vote by an FDA advisory panel earlier this month in favor of the expanded approval.
Perjeta was originally approved in 2012 to treat patients with advanced or late-stage HER2-positive breast cancer. It can now be used prior to surgery in patients with HER2-positive, locally advanced, inflammatory or early-stage breast cancer who are at high risk of having their cancer return or spread, the agency said.