FDA Approves First Pre-Surgical Breast Cancer Drug
WASHINGTON - Federal health officials say they have approved a biotech drug from Roche called Perjeta as the first medicine labeled for the treatment of breast cancer before surgery.
The Food and Drug Administration approved the drug for women with a form of early-stage breast cancer who face a high risk of having their cancer spread to other parts of the body.
Surgery to remove tumors is usually the first step in treating most forms of cancer. Perjeta is the first drug to be approved as a pre-surgical step.
The FDA gave the drug accelerated approval based on a study showing women who received the drug as an initial treatment were more likely to be cancer-free 12 weeks later than women who received older drug combinations.