FDA advisory panel backs new indication for Genentech's Perjeta

The US Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) yesterday (September 13) voted 13 to 0, with one abstention, in favor of recommending accelerated approval of Swiss drug major Roche (ROG: SIX) subsidiary Genentech’s Perjeta (pertuzumab) for neoadjuvant treatment (use before surgery) in people with high-risk, HER2-positive early stage breast cancer.

The FDA will make a decision on whether or not to approve Perjeta for this use by October 31, 2013. If approved, the Perjeta regimen will be the first neoadjuvant breast cancer treatment approved in the United States and the first treatment approved based on pathological complete response (pCR) data, meaning there is no tumor tissue detectable at the time of surgery.

ODAC chairman Mikkael Sekeres, an associate professor of medicine at the Cleveland Clinic, called the vote "a historic moment," adding: "We are supporting the movement of a highly active drug for metastatic breast cancer to the first-line setting, with the hope that women with earlier stages of breast cancer will live longer and better."