FDA Grants Pembrolizumab Priority Review for Advanced SCLC

February 20, 2019 – The FDA has granted a priority review designation to a supplemental biologics license application (sBLA) for pembrolizumab as a treatment for patients with advanced small cell lung cancer (SCLC) whose disease has progressed following ≥2 prior lines of therapy. The application is based on findings from cohorts of the phase II KEYNOTE-158 and phase Ib KEYNOTE-028 studies, in which pembrolizumab elicited 19% and 33% … (leggi tutto)