BASEL, Switzerland—Roche has announced that the U.S. Foodand Drug Administration (FDA) has approved Perjeta (pertuzumab) for the treatment of people with HER2-positivemetastatic breast cancer (mBC) who have not received prior anti-HER2therapy or chemotherapy for metastatic disease.For this indication, Perjeta is approved in combination with Herceptin (trastuzumab) anddocetaxel chemotherapy.
This approval is basedon data from a Phase III study which showed that people with previouslyuntreated HER2-positive mBC who received the combination of Perjeta,Herceptin and docetaxel chemotherapy enjoyed a median of 6.1 months longerwith 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 onlyregimen to have shown a significant improvement in PFS compared to Herceptin plus chemotherapy in people withpreviously untreated HER2-positive metastatic breast cancer.
As Roche explains, Perjeta is a personalized medicine that targets the HER2 receptor, aprotein found in high quantities on the outside of cells inHER2-positive cancers. Perjeta is believed to work in a way that iscomplementary to Herceptin, as the two medicines target differentregions on the HER2 receptor.
"Today's approval of Perjeta is an important advance in the treatmentof HER2-positive metastatic breast cancer," said Dr. Hal Barron, chief medical officer and head of global product development for Roche. "Perjetaattacks HER2-positive tumors differently than Herceptin. Based on theway the two medicines work together, the combination plus chemotherapycan prolong the time before this aggressive cancer worsens compared toHerceptin and chemotherapy alone. We are very pleased to see ourefforts in studying the science of HER2 translate into anotherpersonalized medicine."
With the approval, Roche has agreed to post-marketing commitmentsrelated to the manufacturing process for Perjeta. These include FDAreview 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 futuresupply of the medicine," said Dr. Patrick Y. Yang, head of Roche's PharmaGlobal Technical Operations. "We take this very seriously and areworking with the FDA to ensure a consistent manufacturing process thatmaintains drug supply for the people who need it."
Roche has also submitted a Marketing Authorization Application to theEuropean Medicines Agency (EMA) for Perjeta in combination withHerceptin and docetaxel chemotherapy for the treatment of previouslyuntreated HER2-positive mBC or locally recurrent, unresectable(inoperable) breast cancer, in patients who have not received previoustreatment or whose disease has returned after treatment in theearly-stage setting. This application is currently under review by theEMA.
SOURCE: Roche news release