First immunotherapy approved in the EU for lung cancer treatment The programmed cell death receptor 1 (PD-1) inhibitor nivolumab (Bristol-Myers Squibb) has been approved in the EU for the treatment of patients with locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) that has progressed on chemotherapy. Squamous non-small cell lung cancer accounts for approximately 25-30% of all lung cancers. The drug, under the trade name Nivolumab, will then be available in all 28 member states of the European Union for the treatment of locally advanced or metastatic squamous lung cell lung cancer. The other approved indication for the drug is malignant melanoma, however, under the trade name Opdivo, and the company said the reason for the two different trade names was to gain rapid approval in different areas. The pivotal study for the drug’s approval was based on the results of CheckMate 017, published in the New England Journal of Medicine. The study evaluated the outcomes of Nivolumab and doxorubicin for the treatment of squamous non-small cell lung cancer that had progressed on platinum-based therapy. Nivolumab had an almost 1-fold increase in 1-year survival compared with doxorubicin (42% vs 24%; HR: 0.59; P = .0002), with median survival (OS) of 9.2 months and 6 months, respectively. Nivolumab treatment-related adverse events (AEs) occurred less frequently: nivolumab: any grade, 58%; grades III-IV, 6.9%; docetaxel: any grade, 86%; grades III-IV, 55%. The incidence of AEs leading to nivolumab treatment discontinuation was 3.1%, much lower than the 10.1% discontinuation rate due to docetaxel. Pneumonia (1.5%) was the most common side effect in the nivolumab group, while a common adverse effect of doxorubicin was peripheral neuropathy (3.1%). The approval of this drug for the treatment of squamous lung cell lung cancer is a major development in this field, which is of great significance for improving the prognosis of squamous lung cell lung cancer and will greatly benefit the majority of lung cancer patients. It is expected that patients in China will benefit from this in the near future! We look forward to this day coming soon!