The FDA has approved Roche’s Perjeta (pertuzumab) 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.

The approval is based on data from a phase III study which showed patients 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).

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.

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 Patrick Y. Yang, Ph.D., head of pharma global technical operation, Roche.  “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 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.