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FDA Grants Frontline Pembrolizumab Regimen Priority Review for Squamous NSCLC

Jason M. Broderick @jasoncology
Published: Monday, Jul 02, 2018

Dr. Roy Baynes

Roy Baynes, MD, PhD
The FDA has granted a priority review designation to a supplemental biologics license application (sBLA) for first-line pembrolizumab (Keytruda) for use in combination with carboplatin/paclitaxel or nab-paclitaxel (Abraxane) for the treatment of patients with metastatic squamous non–small cell lung cancer (NSCLC), regardless of PD-L1 expression.

), plus pembrolizumab (200 mg every 3 weeks) or placebo for 4 cycles (each 3 weeks), followed by single-agent pembrolizumab (200 mg every 3 weeks) or placebo for up to 31 cycles, for a potential total of 35 cycles.

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