FDA Grants Atezolizumab Combo Priority Review for Frontline TNBC

November 13, 2018 – The FDA has granted a priority review designation to a supplemental biologics license application (sBLA) for the frontline combination of atezolizumab plus nab-paclitaxel for patients with unresectable locally advanced or metastatic PD-L1–positive triple-negative breast cancer (TNBC). The sBLA is based on the phase III IMpassion130 trial, in which the addition of the PD-L1 inhibitor atezolizumab to nab-paclitaxel reduced the risk of progression or … (leggi tutto)