FDA Approval Summary: Nivolumab for the Treatment of Metastatic Non-Small Cell Lung Cancer With Progression On or After Platinum-Based Chemotherapy

Abstract

In the CheckMate 057 trial, an international, multicenter, open-label, randomized trial in patients with metastatic nonsquamous non-small cell lung cancer with progression on or after platinum-based chemotherapy, improved overall survival and objective response rates were demonstrated with nivolumab compared with docetaxel. Progression-free survival did not differ between the two arms of the study.

Non–Small Cell Lung Cancer, Version 5.2017, NCCN Clinical Practice Guidelines in Oncology

“…Nivolumab: The NCCN panel recommends nivolumab (category 1) as subsequent therapy for patients with metastatic nonsquamous NSCLC that has progressed on or after first-line chemotherapy based on data from a phase III randomized trial (CheckMate-057) and FDA approval (see NSCL-24, page 513). 171,190 Nivolumab inhibits PD-1 receptors. 175 The category 1 recommendation for nivolumab is based on the published data from CheckMate-057 and FDA approval of nivolumab for patients with metastatic nonsquamous NSCLC.…”

Durable complete response to nivolumab in a patient with HIV and metastatic non-small cell lung cancer

“…Both trials demonstrated a significant increase in overall survival compared to docetaxel (3,6). This increase in overall survival leads to the FDA approval of nivolumab for the treatment of metastatic squamous NSCLC after prior platinum-based chemotherapy (7). However, patients with HIV were excluded from both of these trials.…”

Urgent need to define Pretreatment predictors of immune check point inhibitors related endocrinopathies: A case report and review of literature

“…[6,7] A series of checkmate trials have led to the accelerated approval of these immune check point inhibitors in the treatment of metastatic melanoma, renal cell cancer, non-small cell lung cancer, small cell cancer and urothelial cancer. [8][9][10][11][12][13][14] Also, its use in the treatment of hepatocellular cancer is under an expedited review by FDA. [15] The first CTLA-4 inhibitor in the market was ipilimumab and one of the most widely used PD-1 inhibitor is nivolumab.…”