Roche group Genentech has secured approval of Perjeta in combination with Herceptin (trastuzumab) and chemotherapy for adjuvant treatment of a specific type of early breast cancer in the US.
The decision allows physicians to prescribe for HER2-positive early breast cancer (EBC) at high risk of recurrence.
In the Phase III APHINITY study, the Perjeta (pertuzumab), Herceptin and chemotherapy regimen significantly cut the risk of invasive breast cancer recurrence or death by 18 percent compared to Herceptin and chemotherapy alone.
Approval of Perjeta “means people with HER2-positive early breast cancer at high risk of recurrence have a new, clinically meaningful treatment option to reduce the chances of their disease returning,” said Sandra Horning, chief medical officer and head of Global Product Development.
US regulators have also converted accelerated approval of the Perjeta-based regimen to full approval for neoadjuvant treatment of HER2-positive, locally advanced, inflammatory, or early stage breast cancer.
Perjeta is also cleared for use in combination with Herceptin and docetaxel in people who have metastatic HER2-positive breast cancer who have not received anti-HER2 therapy or chemotherapy for metastatic breast cancer.