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辉瑞提交PD-L1+阿昔替尼治疗晚期肾细胞癌上市申请,获FDA优先审评

医药魔方 医药魔方 来源:医药魔方
2019-02-12
辉瑞 晚期肾细胞癌 优先审评
原文

默克雪兰诺/辉瑞2月12日宣布,FDA已经接受Bavencio(avelumab)+Inlyta(阿昔替尼)治疗晚期肾细胞癌的上市申请(sBLA),并授予优先审评资格,PDUFA预定审批期限是2019年6月。2017年12月,FDA曾授予avelumab+阿昔替尼一线治疗晚期RCC突破性疗法资格。


肾细胞癌是最常见的肾癌类型,占肾癌患者的70%左右,占成人全部类型癌症患者的2%-3%。尽管晚期肾细胞癌有相应的治疗药物,但是患者的预后仍然很差。大约20%-30%的肾细胞癌患者在初次确认时已经处于转移的晚期阶段,这类患者的5年生存率大约为12%。2019年美国大约有73820例新确诊RR患者。


该项sBLA主要基于III期JAVELIN Renal 101研究的数据。


avelumab的临床开发项目名称为JAVELIN,共涉及超过30项临床试验,入组了超过9000例患者,考察了15种不同类型的肿瘤,除了RCC之外,还包括乳腺癌、胃癌/胃食管连接部癌、头颈癌、默克尔细胞癌、NSCLC、尿路上皮癌等。


机器翻译

Merck Serono/Pfizer announced on February 12 that FDA has accepted Bavencio (avelumab) + Inlyta (axitinib) for the treatment of advanced renal cell carcinoma (sBLA) and granted priority for review. PDUFA has a scheduled approval period of June 2019.In December 2017, the FDA granted avelumab plus axitinib as a first-line breakthrough therapy for advanced RCC.

Renal cell carcinoma is the most common type of renal cancer, accounting for about 70% of renal cancer patients and 2% -3% of all types of adult cancer patients.Despite the availability of therapeutic agents for advanced RCC, the prognosis remains poor.Approximately 20% to 30% of patients with RCC are already at an advanced stage of metastasis at initial confirmation, and the 5-year survival rate for such patients is approximately 12%.There were approximately 73,820 newly diagnosed RR patients in the United States in 2019.

This sBLA is based primarily on data from the Phase 3 JAVELIN Renal 101 study.

avelumab's clinical development program, called JAVELIN, involves more than 30 clinical trials, has enrolled more than 9,000 patients, and has examined 15 different types of tumors, including breast cancer, in addition to RCC.Gastric/gastroesophageal junction cancer.Head and neck cancer.Merkel cell carcinoma.NSCLC.Urothelial carcinoma, etc.

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