Anlotinib for Refractory Advanced Non–small Cell Lung Cancer in China

To the Editor Aguiar and colleagues reported the negative cost-effectiveness of first-line osimertinib for EGFR-mutated advanced non–small cell lung cancer (NSCLC). Anlotinib hydrochloride (AL3818), a novel oral multitarget tyrosine kinase inhibitor, was approved as a third-line treatment for refractory advanced NSCLC by the China Food and Drug Administration (CFDA) on May 9, 2018. Anlotinib targets vascular endothelial growth factor receptors, fibroblast growth factor receptors, platelet-derived growth factor receptors, and c-kit, which are involved in broad-spectrum inhibition of tumor angiogenesis and growth. In the phase 1 trial, anlotinib appeared to have broad antitumor capacity for refractory advanced solid tumors, with acceptable and manageable toxic effects, including hypertension, dermal toxic effects, and hypertriglyceridemia. In the phase 2 trial (NCT01924195) on refractory metastatic or recurrent NSCLC, third-line anlotinib treatment had a significant progression-free survival benefit compared with placebo (4.8 vs 1.2 months; P < .001). Subsequently, in the phase 3 trial (NCT02388919) in a similar setting, anlotinib improved the overall survival compared with placebo (9.6 vs 6.3 months; P = .002), with manageable toxic effects. Based on these serial phase 1 to 3 trials, the CFDA gave anlotinib rapid approval to market according to the updated governmental strategy for accelerated new drug approval. The drug met the requirements of controlling the heavy burden associated with lung cancer and decreasing the cost of new drug development in China.

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