Perjeta Approved for Early Stage Breast Cancer
MONDAY Sept. 30, 2013 -- The anti-cancer drug Perjeta (pertuzumab) has been approved by the U.S. Food and Drug Administration to treat early-stage breast cancer before surgery, the agency said Monday.
In 2012, the drug was approved to treat advanced or spreading (metastatic) HER-2 positive breast cancer, which is triggered by increased amounts of a protein that fuels the growth of cancer cells, the FDA said in a news release.
The drug's new use is meant for people with HER-2 positive early-stage breast cancer who are at increased risk of the cancer returning, spreading or of dying from the disease, the agency said. The drug is to be used with in combination with chemotherapy before surgery.
Perjeta's safety and effectiveness were evaluated for the new use in a clinical study involving 417 people, the FDA said. A "confirmatory" study involving more than 4,800 people is ongoing, with results expected in 2016.
Perjeta is marketed by San Francisco-based Genentech, a member of the Roche Group.
To learn more about this approval, visit the FDA.
Posted: September 2013