The U.S. Food and Drug Administration has granted accelerated approval to Perjeta® (pertuzumab; Genentech) as part of a neoadjuvant treatment regimen for patients with high-risk, HER2-positive, early-stage breast cancer.

This approval is based on a phase 2 study of 417 participants that found nearly 40% of those who received Perjeta plus trastuzumab and docetaxel achieved pathologic complete response (pCR) compared with approximately 21% who received trastuzumab plus docetaxel.

The new indication for Perjeta is for patients with locally advanced, HER2-positive, inflammatory or early-stage breast cancer who are at high risk of recurrence, metastases, or death from the disease. The drug should be used in combination with trastuzumab and other chemotherapy before surgery and may be followed by chemotherapy post-surgery, depending on the treatment regimen used. After surgery, patients should continue to receive trastuzumab to complete 1 year of treatment.

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A confirmatory study for this approval examining 4,800 participants with HER2-positive breast cancer who previously underwent breast cancer surgery and are at high risk of recurrence is ongoing, and results are expected in 2016. 

Perjeta is the first FDA-approved drug for the neoadjuvant treatment of breast cancer, and the first to be approved based on pCR data. It was first approved in 2012 for treatment of advanced or late-stage HER2-positive breast cancer.

Related: Perjeta Under Priority Review for use Before Surgery in HER2-Positive Breast Cancer


FDA approves Perjeta for neoadjuvant breast cancer treatment [news release]. U.S. Food and Drug Administration; October 30, 2013. Accessed October 30, 2013.