FDA Delays Decision on Frontline Pembrolizumab sBLA in NSCLC

December 21, 2018 – The FDA has extended the review period for a supplemental biologics license application (sBLA) for single-agent pembrolizumab for the frontline treatment of patients with locally advanced or metastatic nonsquamous or squamous non–small cell lung cancer (NSCLC) with a PD-L1 expression (tumor proportion score [TPS]) level of ≥1% and no EGFR or ALK genomic tumor aberrations. Merck (MSD), the manufacturer of pembrolizumab, reported in … (leggi tutto)