Tunlametinib (®) 是一种口服、选择性、丝裂原激活蛋白激酶激酶 1 和 2 (MEK 1/2) 抑制剂，由上海科侨制药有限公司开发，用于治疗具有 RAS 和 RAF 突变的实体瘤，包括黑色素瘤、非小细胞癌 (NSCLC)、结直肠癌 (CRC) 和 1 型神经纤维瘤病 (NF1) 丛状神经纤维瘤。 2024年3月，tunlametinib在中国获得有条件批准（基于替代终点），用于治疗抗PD-1/PD-L1治疗失败的NRAS突变晚期黑色素瘤患者。本文总结了 tunlametinib 开发的里程碑，该药物首次获批用于治疗具有 RAS 和 RAF 突变的实体瘤。© 2024。作者获得 Springer Nature Switzerland AG 的独家许可。

Tunlametinib (®) is an oral, selective, mitogen-activated protein kinase kinase 1 and 2 (MEK 1/2) inhibitor being developed by Shanghai KeChow Pharma, Inc. for the treatment of solid tumours with RAS and RAF mutations, including melanoma, non-small cell cancer (NSCLC), colorectal cancer (CRC) and neurofibromatosis type 1 (NF1) plexiform neurofibromas. In March 2024, tunlametinib was granted conditional approval in China (based on surrogate endpoints) for use in patients with NRAS-mutated advanced melanoma who have failed anti-PD-1/PD-L1 treatment. This article summarizes the milestones in the development of tunlametinib leading to this first approval for the treatment of solid tumours with RAS and RAF mutations.© 2024. The Author(s), under exclusive licence to Springer Nature Switzerland AG.