FDA Grants Frontline Pembrolizumab Priority Review for Lower PD-L1 Cutoff in NSCLC

September 12, 2018 – The FDA has granted a priority review designation to 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. The sBLA is based on data from the phase … (leggi tutto)