Pertuzumab in neoadjuvant treatment of HER2-positive early breast cancer

Pertuzumab injection was granted accelerated approval by the US Food and Drug Administration last fall for use in combination with trastuzumab plus docetaxel for neoadjuvant treatment of patients with HER2-positive locally advanced, inflammatory, or early-stage breast cancer (either > 2 cm in diameter or node-positive) as part of a complete treatment regimen for early breast cancer. The accelerated approval was based on improvement in pathologic complete response (pCR) rate in a phase 2 trial. Data showing improved event-free survival or overall survival are not yet available. Continued approval for this indication is contingent on demonstration of improvement in disease-free survival in a confirmatory trial.