BASEL, Switzerland—Roche has announced that the U.S. Food and Drug Administration (FDA) has approved Perjeta (pertuzumab) 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. For this indication, Perjeta is approved in combination with Herceptin (trastuzumab) and docetaxel chemotherapy.  

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 enjoyed a median of 6.1 months longer with progression-free survival (PFS) compared to Herceptin plus docetaxel chemotherapy (median PFS 18.5 months vs. 12.4 months).

 

According to Roche, 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 metastatic breast cancer.  

 

As Roche explains, 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.

 

“Today’s 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 of global product development for Roche. “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.”

 

With the approval, Roche has agreed to post-marketing commitments related to the manufacturing process for Perjeta. These include FDA review of data from the next several productions of the medicine.

 

“We expect to meet demand for Perjeta following today's FDA approval. We recently identified a cell growth issue that might affect our future supply of the medicine,” said Dr. Patrick Y. Yang, head of Roche's Pharma Global Technical Operations. “We take this very seriously and are working with the FDA to ensure a consistent manufacturing process that maintains drug supply for the people who need it.”

 

Roche has also submitted a Marketing Authorization Application to the European Medicines Agency (EMA) for Perjeta in combination with Herceptin and docetaxel chemotherapy for the treatment of previously untreated HER2-positive mBC or locally recurrent, unresectable (inoperable) breast cancer, in patients who have not received previous treatment or whose disease has returned after treatment in the early-stage setting. This application is currently under review by the EMA.

 

SOURCE: Roche news release