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FDA Approval Sought for Frontline Pembrolizumab Combo in Squamous NSCLC

Jason M. Broderick @jasoncology
Published: Thursday, May 03, 2018

A supplemental biologics license application (sBLA) has been submitted to the FDA for the use of pembrolizumab (Keytruda) in combination with standard chemotherapy as a treatment for patients with metastatic squamous non–small cell lung cancer (sNSCLC), according to Merck (MSD), the manufacturer of the PD-1 inhibitor.

Pembrolizumab is already approved as a single agent for the treatment of patients with metastatic squamous NSCLC.

References

  1. Papadimitrakopoulou V, Gadgeel SM, Borghaei H, et al. First-line carboplatin and pemetrexed (CP) with or without pembrolizumab (pembro) for advanced nonsquamous NSCLC: Updated results of KEYNOTE-021 cohort G. J Clin Oncol. 2017;35 (suppl; abstr 9094).
  2. Gandhi L, Rodgríguez-Abreu D, Gadgeel S, et al. KEYNOTE-189: Randomized, double-blind, phase 3 study of pembrolizumab (pembro) or placebo plus pemetrexed (pem) and platinum as first-line therapy for metastatic NSCLC. Presented at 2018 AACR Annual Meeting; April 14-18, 2018; Chicago, Illinois. Abstract CT075.
  3. Gandhi L, Rodgríguez-Abreu D, Gadgeel S, et al. Pembrolizumab plus chemotherapy in metastatic non–small-cell lung cancer [published online April 16, 2018]. N Engl J Med. doi: 10.1056/NEJMoa1801005.

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