The FDA Approved Perjeta® (pertuzumab)
The FDA recently approved Perjeta® (pertuzumab), in combination with Herceptin® (trastuzumab) and chemotherapy (the Perjeta-based regimen), for adjuvant (after surgery) treatment of HER2-positive early breast cancer (EBC) at high risk of recurrence. The Genentech press release including Important Safety Information is linked here.
This approval is important because:
- It is based on results of the Phase III APHINITY study, which showed adjuvant treatment with Perjeta, Herceptin and chemotherapy significantly reduced the risk of invasive breast cancer recurrence or death compared to Herceptin and chemotherapy alone.
- Despite significant advances in the treatment of HER2-positive early breast cancer, there is still a chance that cancer cells may remain in the body after surgery, and the cancer may return.
- The goal of treating early breast cancer after surgery is to reduce the risk of the cancer coming back.
- With this approval, the previously granted accelerated approval of the Perjeta-based regimen for neoadjuvant (before surgery) treatment of HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than two centimeters in diameter or node-positive) has been converted to full approval.
Visit Genentech’s breast cancer page on gene.com for more on our approach to breast cancer.
