Posted by Michael Wonder on 29 Sep 2017
FDA grants priority review for Roche’s Perjeta (pertuzumab) for adjuvant treatment of HER2-positive early breast cancer
29 September 2017 - Roche today announced the US FDA has accepted the company’s supplemental biologics license application 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.
The FDA is expected to make a decision on approval by 28 January 2018.
The application is based on results of the phase III APHINITY study.
