FDA批准Gilotrif用于某些晚期肺癌患者

圣路易斯(MD Consult)——2013年7月12日，美国食品药品管理局(FDA)宣布，已批准将Gilotrif(阿法替尼)用于治疗在伴随诊断检测(therascreen EGFR RGQ PCR试剂盒)中发现有表皮生长因子(EGFR)外显子19删除或外显子21 L858R取代基因突变的晚期(转移性)非小细胞肺癌(NSCLC)患者。Gilotrif是一种酪氨酸激酶抑制剂，可阻断促进癌细胞发育的蛋白质。

在一项纳入345例EGFR突变性转移性NSCLC患者的临床研究中，明确了Gilotrif的安全性和有效性。将受试者随机分组，给予Gilotrif或不超过6个周期的培美曲塞加顺铂治疗。结果显示，接受Gilotrif治疗者的无进展生存期较接受化疗者延长了4.2个月。两组总生存期未见统计学差异。

与使用Gilotrif相关的常见不良反应包括腹泻、类似痤疮的皮肤突起、皮肤干燥、瘙痒、口腔炎症、甲沟炎、食欲减退、体重减轻、膀胱炎、鼻衄、鼻溢、发热、眼部炎症和低钾血症。严重不良反应包括可导致肾衰竭和重度脱水的腹泻、重度皮疹、肺部炎症和肝脏毒性。

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ST LOUIS (MD Consult) - On July 12, 2013, the US Food and Drug Administration (FDA) announced the approval of Gilotrif (afatinib) for the treatment of patients with late-stage (metastatic) non-small cell lung cancer (NSCLC) whose tumors express epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution gene mutations, as detected by a newly approved companion diagnostic test (therascreen EGFR RGQ PCR Kit). Gilotrif is a tyrosine kinase inhibitor that blocks proteins that promote the development of cancerous cells.

Gilotrif's safety and effectiveness were established in a clinical study of 345 participants with metastatic NSCLC whose tumors harbored EGFR mutations. Participants were randomly assigned to receive Gilotrif or up to 6 cycles of pemetrexed and cisplatin. Participants receiving Gilotrif experienced progression-free survival that was 4.2 months longer than those receiving chemotherapy. No statistically significant difference in overall survival was noted.

Common adverse effects associated with the use of Gilotrif include diarrhea, skin breakouts that resemble acne, dry skin, pruritus, inflammation of the mouth, paronychia, decreased appetite, decreased weight, cystitis, epistaxis, rhinorrhea, fever, eye inflammation, and hypokalemia. Serious adverse effects include diarrhea that can result in kidney failure and severe dehydration, severe rash, lung inflammation, and liver toxicity.