Genentech announced that the FDA has granted accelerated approval of Perjeta (pertuzumab) as part of a neoadjuvant regimen in patients with high-risk HER2-positive early stage breast cancer

The Perjeta regimen is the first FDA-approved neoadjuvant breast cancer treatment, and the first to be approved based on pathological complete response (pCR) data.

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This accelerated approval is based on data from a Phase 2 study that demonstrated nearly 40% of patients receiving Perjeta, in combination with trastuzumab (Herceptin; Genentech) and docetaxel, demonstrated pCR. pCR indicates that there is no evidence of tumor tissue detectable at the time of surgery.

Perjeta is a human epidermal growth factor receptor (HER2) dimerization inhibitor currently indicated to treat patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease, in combination with trastuzumab and docetaxel. 

Perjeta was granted priority review by the FDA in July 2013 for its use before surgery as part of a neoadjuvant regimen.

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