and Request YES NO ABSTAIN ABSENT NSCL-3, NSCL-9, NSCL-10, NSCL-E Internal request: Panel review of the data in response to the FDA Based on the data in the noted references, the Panel 28 0 1 3 approval of nivolumab in combination with platinum- consensus supported the addition of nivolumab in doublet chemotherapy for patients with resectable combination with platinum-doublet chemotherapy for (tumors ≥4 cm or node positive) NSCLC in the patients with resectable (tumors ≥4 cm or node positive) neoadjuvant setting. NSCLC in the neoadjuvant setting. If an immune checkpoint inhibitor is used in the pre-operative setting, External request: an immune checkpoint inhibitor should not be used in the Submission from Bristol Myers Squibb, requesting the adjuvant setting. addition of nivolumab in combination with platinum- doublet chemotherapy as neoadjuvant systemic This recommendation is a category 2A. treatment for adult patients with resectable (tumors ≥4 cm or node positive) NSCLC prior to definitive surgery. • Forde PM, Spicer J, Lu S, et al. Nivolumab (NIVO) + platinum-doublet chemotherapy (chemo) vs chemo as neoadjuvant treatment (tx) for resectable (IB-IIIA) non-small cell lung cancer (NSCLC) in the phase 3 CheckMate 816 trial [abstract]. Cancer Res 2021;81:Abstract CT003. • See Submission for references.
Efficacy, Safety, and Health-Related Quality of Life With Camrelizumab Plus Pemetrexed and Carboplatin As First-Line Treatment For Advanced Nonsquamous NSCLC With Brain Metastases
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