Real-world safety of nivolumab in patients with non-small cell lung cancer (NSCLC) in Japan: Interim summary of post-marketing all-case surveillance

Background: Nivolumab, a fully humanized anti-PD-1 antibody, was approved in December 2015 in Japan for the treatment of previously-treated, unresectable, advanced or recurrent NSCLC. A post-marketing all-case surveillance was imposed as a condition for approval, to accumulate real-world safety data for nivolumab, because clinical trial data were limited. Methods: This all-case surveillance is an ongoing mandatory observational register,...