11 Jun 2012, BioSpectrum Bureau , BioSpectrum
Singapore: The US Food and Drug Administration (FDA) has approved Genentech's Perjeta for people with her2-positive metastatic breast cancer. 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 that 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.
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.
Perjeta is a personalized medicine that targets the HER2 receptor, a protein found in high quantities on the outside of cells in HER2-positive cancers. Perjeta is believed to work in a way that is complementary to Herceptin, as the two medicines target different regions on the HER2 receptor.
"Approval of Perjeta is an important advance in the treatment of HER2-positive metastatic breast cancer," said Dr Hal Barron, chief medical officer and head, Global Product Development, Genentech. "Perjeta attacks HER2-positive tumors differently than Herceptin. Based on the way the two medicines work together, the combination plus chemotherapy can prolong the time before this aggressive cancer worsens compared to Herceptin and chemotherapy alone. We are very pleased to see our efforts in studying the science of HER2 translate into another personalized medicine."