martedì, 24 novembre 2020
26 Ottobre 2018

FDA Extends Review Period for Frontline Nivolumab/Ipilimumab in TMB-High NSCLC

October 22, 2018 – The FDA has added 3 months to the review period for the combination of nivolumab plus low-dose ipilimumab for the frontline treatment of patients with advanced non–small cell lung cancer (NSCLC) with tumor mutational burden (TMB) ≥10 mutations per megabase (mut/Mb), making the new action date May 20, 2019. The extension in the review timeline for the supplemental biologics license application (sBLA) for the immunotherapy combination … (leggi tutto)