治疗非小细胞肺癌新药——劳拉替尼(lorlatinib)
摘要
由美国辉瑞制药有限公司研制的劳拉替尼(lorlatinib)是第三代非小细胞肺癌(NSCLC)治疗新药,具有间变性淋巴瘤激酶(ALK)和c-ros原癌基因1(ROS1)双重受体酪氨酸激酶(RTK)抑制作用,用于治疗既往接受过至少一种ALK抑制药治疗,但病情进展的ALK阳性和(或) ROS1阳性转移性NSCLC患者。美国食品药品管理局(FDA)于2015年10月授予lorlatinib罕用药(orphan drug)认定,2017年4月27日获得FDA突破性治疗药资格和优先审评的待遇,并于2018年11月2日加速批准上市,制剂商品名为Lorbrena;日本医药品医疗器械综合机构(PMDA)于2018年9月21日批准该药上市,片剂商品名为ロルラチニブ;欧洲药品管理局(EMA)人用药品委员会(CHMP) 2019年2月底财政年度会议纪要中,对lorlatinib的安全性和有效性持正面意见,建议EMA批准上市,制剂商品名将命名为Lorviqua。该文对lorlatinib非临床和临床药理毒理学、临床研究、不良反应、适应证、剂量与用法、用药注意事项及知识产权状态和国内外研究进展等进行介绍。
引文
[1]BRAY F,FERLAY J,SOERJOMATARAM I,et al.Global cancer statistics 2018:GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries[J].CA Cancer J Clin,2018,68:394-424.
[2]SYED Y Y.Lorlatinib:First global approval[J].Drugs,2019,79(1):93-98
[3]FDA.Lorbrena(lorlatinib)tablets,for oral use[EB/OL](2018-11-02)https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210868s000lbl.pdf
[4]PMDA抗悪性腫瘍剤/チロシンキナーゼ阻害剤ロルラチニブ[EB/OL](2018-09-26)http://www.pmda.go.jp/PmdaSearch/iyaku Detail/Result Data Set PDF/671450_4291055F1020_1_03#page=4
[5]AKAMINE T,TAGAWA T,MORI M,et al.Lorlatinib for the treatment of patients with non-small cell lung cancer[J].Drugs of today(Barcelona,Spain:1998),2019,55(2):107-116
[6]JUNYI Y,WEILIANG G.Lorlatinib for the treatment of anaplastic lymphoma kinase-positive non-small cell lung cancer[J/OL].Expert Review Clin Pharmac,2019,157(8):46.DOI:10.1080/17512433
[7]SOLOMON B J,BESSE B,BAUER T M,et al.Lorlatinib in patients with ALK-positive non-small-cell lung cancer:results from a global phase 2 study[J].Lancet oncology,2018,19(12):1654-1667
[8]SHAW A T,FELIP E,BAUER T M,et al.Lorlatinib in nonsmall-cell lung cancer with ALK or ROS1 rearrangement:an international,multicentre,open-label,single-arm first-inman phase 1 trial[J].Lancet oncology,2017,18(12):1590-1599.
[2]SYED Y Y.Lorlatinib:First global approval[J].Drugs,2019,79(1):93-98
[3]FDA.Lorbrena(lorlatinib)tablets,for oral use[EB/OL](2018-11-02)https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210868s000lbl.pdf
[4]PMDA抗悪性腫瘍剤/チロシンキナーゼ阻害剤ロルラチニブ[EB/OL](2018-09-26)http://www.pmda.go.jp/PmdaSearch/iyaku Detail/Result Data Set PDF/671450_4291055F1020_1_03#page=4
[5]AKAMINE T,TAGAWA T,MORI M,et al.Lorlatinib for the treatment of patients with non-small cell lung cancer[J].Drugs of today(Barcelona,Spain:1998),2019,55(2):107-116
[6]JUNYI Y,WEILIANG G.Lorlatinib for the treatment of anaplastic lymphoma kinase-positive non-small cell lung cancer[J/OL].Expert Review Clin Pharmac,2019,157(8):46.DOI:10.1080/17512433
[7]SOLOMON B J,BESSE B,BAUER T M,et al.Lorlatinib in patients with ALK-positive non-small-cell lung cancer:results from a global phase 2 study[J].Lancet oncology,2018,19(12):1654-1667
[8]SHAW A T,FELIP E,BAUER T M,et al.Lorlatinib in nonsmall-cell lung cancer with ALK or ROS1 rearrangement:an international,multicentre,open-label,single-arm first-inman phase 1 trial[J].Lancet oncology,2017,18(12):1590-1599.