FDA Approves Perjeta for Early-Stage Breast Cancer
Perjeta is first FDA-approved drug for neoadjuvant treatment of breast cancer
MONDAY, Sept. 30 (HealthDay News) -- The 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 late-stage (metastatic) HER2 (human epidermal growth factor receptor 2)-positive breast cancer, the FDA said in a news release.
The drug's new use is meant for people with HER2-positive early-stage breast cancer who are at increased risk of the cancer returning or spreading or of dying from the disease, the agency said. The drug is to be used 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.