FDA accepts sBLA for Perjeta (pertuzumab) + Herceptin (trastuzumab) for adjuvant (after surgery) treatment of HER2-positive early breast cancer. Genentech/Roche

Genentech, announced the FDA has accepted the company�s supplemental Biologics License Application (sBLA) and granted Priority Review for 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). The FDA is expected to make a decision on approval by 28 January 2018.

The sBLA is based on results of the Phase III APHINITY study. A Priority Review designation is granted to medicines that the FDA has determined to have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease.

This sBLA seeks to convert the current accelerated approval to full approval. In the U.S., the combination of Perjeta, Herceptin and docetaxel chemotherapy is currently available under accelerated approval for neoadjuvant treatment of people with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than two centimeters in diameter or node-positive) as part of a complete treatment regimen for early breast cancer. Currently, no data have shown whether or not treatment with Perjeta prior to surgery improves survival. The safety of Perjeta in combination with doxorubicin-containing regimens has not been established. The safety of Perjeta administered for greater than six cycles for early-stage breast cancer has not been established. Perjeta is also approved for use in combination with Herceptin and docetaxel for people who have HER2-positive breast cancer that has spread to different parts of the body (metastatic) and who have not received anti-HER2 therapy or chemotherapy for metastatic breast cancer.