FDA Pipeline: New Priority Reviews, Designations, and Clearances, Plus Statements on Genetic Testing and Class Labeling

December 11, 2018 – The FDA accepted a supplemental biologics license application (sBLA) and granted Priority Review for atezolizumab in combination with carboplatin and etoposide for the first-line treatment of patients with extensive-stage small cell lung cancer (SCLC). The FDA is expected to make a decision on approval by March 18, 2019. This sBLA is based on results from the phase III IMpower133 study, a multicenter, double-blinded, randomized placebo- … (leggi tutto)