Roche’s sBLA for Perjeta for adjuvant treatment of HER2-positive early breast cancer gets US FDA priority review status

Roche has announced the US Food and Drug Administration (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.

The combination of Perjeta, Herceptin and chemotherapy is licensed as a neoadjuvant (before surgery) treatment for people with HER2-positive eBC in more than 85 countries worldwide following approvals by the European Medicines Agency (EMA) and the US FDA. In the US, the regimen is currently available under the FDA Accelerated Approval Program. This sBLA seeks to convert the current accelerated approval to full approval in the US. Additionally, the APHINITY trial reflects the commitment to evaluate the Perjeta-based regimen as part of a complete treatment approach for eBC. Perjeta in combination with Herceptin and docetaxel chemotherapy is also approved in the US and the European Union for people with previously untreated HER2-positive metastatic breast cancer.