目的:2022 年 3 月 4 日,美国食药管理局 (FDA) 批准纳武利尤单抗联合铂类双药化疗用于可切除非小细胞肺癌 (NSCLC) 患者的新辅助治疗。本文讨论了FDA通过该批准的关键数据和监管考虑的审查。 PATIENTS AND METHODS: The approval was based on the results of CheckMate...
CheckMate 577 demonstrated a significant benefit with adjuvant nivolumab for those with residual disease after esophagectomy following chemoradiation, resulting in subsequent FDA approval and guideline inclusion. We analyzed adherence to this recommendation in a non-trial setting and assessed for factors ...
Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO. OPDIVO® (nivolumab), in combination with YERVOY...
In July 2014,Opdivowas the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world.Opdivois currently approved in more than 65 countries, including the United States, the European Union, Japan and China. In September 2015, the Company’sOpdivoand...