FDA grants Priority Review for Roche ’s Perjeta (pertuzumab) for adjuvant treatment of HER2-positive early breast cancer

Roche today 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 exp ected to make a decision on approval by 28 January 2018.
Source: Roche Investor Update - Category: Pharmaceuticals Source Type: news