Anlotinib: First Global Approval.

Jiangsu Chia-Tai Tianqing Pharmaceutical and Advenchen Laboratories are co-developing anlotinib (Focus V) for the treatment of advanced cancer. Anlotinib is an oral small molecule inhibitor of multiple receptor tyrosine kinases, with a broad spectrum of inhibitory effects on tumour angiogenesis and growth. Anlotinib is approved in China for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have undergone progression or recurrence after ≥ 2 lines of systemic chemotherapy. Anlotinib is also undergoing phase II and/or III clinical development for various sarcomas and carcinomas in China, USA and Italy. This article summarizes the milestones in the development of anlotinib leading to this first approval for NSCLC.