First Neoadjuvant Immunotherapy Approved for Early-stage Non-small Cell Lung Cancer 

The FDA approved nivolumab in combination with chemotherapy for use before surgery in certain patients with non-small cell lung cancer  

The U.S. Food and Drug Administration (FDA) has approved the immune checkpoint inhibitor nivolumab (Opdivo) to be used with chemotherapy before surgery in adult patients with early-stage, resectable non-small cell lung cancer (NSCLC).  

Immune checkpoint inhibitors boost the immune response against cancer cells by blocking certain inhibitory molecules that act like switches to turn off immune cells called T cells. This type of immunotherapy had been previously approved to treat NSCLC at later stages of treatment.  

The approval of nivolumab as a pre-surgical therapy was based on results from a randomized, open-label, phase III clinical trial that involved 358 patients with resectable stage IB, II, or IIIA NSCLC. The study participants received either nivolumab plus chemotherapy or chemotherapy alone every three weeks for up to three cycles. 

The median event-free survival was 31.6 months in the nivolumab plus chemotherapy group and 20.8 months in the chemotherapy alone group, with a 37 percent reduction in the risk of disease progression, recurrence, or death in patients who received nivolumab and chemotherapy compared with those who received chemotherapy alone. 

NSCLC is the most common type of lung cancer. According to federal statistics, almost 237,000 cases of lung and bronchus cancer are expected to be diagnosed in the U.S. in 2022. 

The FDA decision was rendered on March 4, 2022.