FDA approves Perjeta (Genentech/Roche) for combination use in metastatic Breast Cancer

Genentech/Roche announced that the FDA has approved Perjeta (pertuzumab). Perjeta is approved in combination with Herceptin (trastuzumab) and docetaxel chemotherapy for the treatment of people with HER2-positive metastatic Breast Cancer (mBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. This approval is based on data from a Phase III study which showed that people with previously untreated HER2-positive mBC who received the combination of Perjeta, Herceptin and docetaxel chemotherapy lived a median of 6.1 months longer without their cancer getting worse (progression-free survival, or PFS) compared to Herceptin plus docetaxel chemotherapy (median PFS 18.5 vs. 12.4 months). The combination of Perjeta, Herceptin and chemotherapy is the only regimen to have shown a significant improvement in PFS compared to Herceptin plus chemotherapy in people with previously untreated HER2-positive mBC.