Genentech announced that the FDA has accepted the company’s Biologics License Application (BLA) for pertuzumab and granted Priority Review for use in combination with Herceptin (trastuzumab; Genentech) and docetaxel chemotherapy for people with HER2+ metastatic or locally recurrent, unresectable breast cancer, who have not received previous treatment or whose disease has relapsed after adjuvant therapy.

The pertuzumab application is based on results from the pivotal Phase 3 CLEOPATRA study, an international, randomized, double-blind, placebo-controlled trial. The study evaluated the efficacy and safety profile of the pertuzumab-based regimen compared to Herceptin and chemotherapy plus placebo in 808 people with previously untreated HER2-positive metastatic breast cancer. The study demonstrated a 6.1 month improvement in median progression-free survival (PFS) for people who received a pertuzumab-based regimen (pertuzumab combined with Herceptin and docetaxel chemotherapy) compared to those who received Herceptin and chemotherapy alone (median PFS 18.5 vs. 12.4 months). People who received the combination also experienced a 38% reduction in the risk of their disease worsening or death (HR=0.62, P<0.0001).

Pertuzumab is a humanized monoclonal antibody being studied in early and advanced stages of HER2+ breast cancer and advanced HER2+ gastric cancer. Pertuzumab is designed specifically to prevent the HER2 receptor from pairing with other HER receptors (EGFR/HER1, HER3 and HER4), a process that is believed to play an important role in the growth and formation of several different cancer types. By preventing receptor pairing, pertuzumab is thought to block cell signaling, which may inhibit cancer-cell growth or lead to the death of the cancer cell. Binding of pertuzumab to HER2 may also signal the body’s immune system to destroy the cancer cells.

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