FDA approves Perjeta
SOUTH SAN FRANCISCO, Calif. — Genentech has received regulatory approval for a drug designed to treat breast cancer.
Perjeta (pertuzumab) is approved in combination with Herceptin (trastuzumab) and docetaxel chemotherapy for the treatment of people with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. With the approval, Genentech 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.
"[Today's] approval of Perjeta is an important advance in the treatment of HER2-positive metastatic breast cancer," said Hal Barron, chief medical officer and head of global product development at 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."