FDA Grants Nivolumab Priority Review for SCLC

April 18, 2018 – The FDA has granted a priority review to a supplemental biologics license application (sBLA) for nivolumab for the treatment of patients with small cell lung cancer (SCLC) with disease progression following 2 or more lines of therapy, according to Bristol-Myers Squibb (BMS), the manufacturer of the PD-1 inhibitor. The sBLA is based on data from the phase I/II CheckMate-032 trial, in which single-agent nivolumab led to a median overall survival … (leggi tutto)