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OCTOBER 17, 2023

FDA Approves Neoadjuvant/Adjuvant Keytruda for Resectable NSCLC

The FDA approved pembrolizumab (Keytruda, Merck) with platinum-containing chemotherapy as neoadjuvant treatment, and with continuation of single-agent pembrolizumab as postsurgical adjuvant treatment for resectable (tumors ≥4 cm or node-positive) non-small cell lung cancer (NSCLC).

Efficacy was evaluated in KEYNOTE-671, a multicenter, randomized, double-blind, placebo-controlled trial in 797 patients with previously untreated and resectable stage II, IIIA or IIIB (N2) NSCLC by the AJCC