First FDA approval of neoadjuvant breast cancer treatment

The US Food and Drug Administration yesterday (September 30) granted accelerated approval for Swiss drug major Roche (ROG: SIX) subsidiary Genentech’s Perjeta (pertuzumab) as part of a complete treatment regimen for patients with early-stage breast cancer before surgery (neoadjuvant setting). Perjeta is the first FDA-approved drug for the neoadjuvant treatment of breast cancer, the FDA noted.

Perjeta was approved in 2012 for the treatment of patients with advanced or late-stage (metastatic) HER2-positive breast cancer. HER2-positive breast cancers have increased amounts of the HER2 protein that contributes to cancer cell growth and survival, the FDA noted.

Perjeta’s new use is intended for patients with HER2-positive, locally advanced, inflammatory or early-stage breast cancer (tumor greater than 2cm in diameter or with positive lymph nodes) who are at high risk of having their cancer return or spread (metastasize) or of dying from the disease. It is to be used in combination with trastuzumab, (Roche’s Herceptin), and other chemotherapy prior to surgery and, depending on the treatment regimen used, may be followed by chemotherapy after surgery. Following surgery, patients should continue to receive trastuzumab to complete one year of treatment.