US FDA approves Roche’s Perjeta for early breast cancer

The US FDA has granted accelerated extended approval to Roche's Perjeta for patients with early stage breast cancer before surgery. Perjeta (pertuzumab) is the first FDA-approved drug for the neoadjuvant treatment of breast cancer.

Perjeta was approved in 2012 for the treatment of patients with advanced or metastatic HER2-positive breast cancer. It's new use is intended for patients with HER2-positive, locally advanced, inflammatory or early stage breast cancer who are at high risk of having their cancer return or spread or of dying from the disease. It is to be used in combination with trastuzumab and other chemotherapy prior to surgery and, depending upon 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.

"We are seeing a significant shift in the treatment paradigm for early stage breast cancer. By making effective therapies available to high-risk patients in the earliest disease setting, we may delay or prevent cancer recurrences.''

Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research.

Perjeta's accelerated approval for neoadjuvant treatment is based on a clinical trial that was designed to measure pathologic complete response (pCR). The confirmatory trial for this accelerated approval is being conducted in more than 4,800 participants with HER2-positive breast cancer who had prior breast cancer surgery and are at high risk of having their cancer return. Results are expected in 2016.

Breast cancer is the second leading cause of cancer-related death among women. An estimated 232,340 women will be diagnosed with breast cancer, and 39,620 will die from the disease in 2013, according to the National Cancer Institute.