USFDA grants priority review to Merck’s sBLA for KEYTRUDA

美国食品和药物管理局给予默克公司对KEYTRUDA的sBLA优先审查

2021-08-11 21:30:12 PHARMACEUTICAL

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The US Food and Drug Administration has granted priority review for Merck’s supplemental biologics license application for KEYTRUDA as adjuvant therapy for patients with renal cell carcinoma . The latest move follows the receipt of a Complete Response Letter (CRL) from the USFDA for the company’s sBLA for KEYTRUDA , an anti-programmed death receptor-1 (PD-1) therapy, in March this year. The sBLA allows the use of the therapy for patients at intermediate-high or high risk for recurrence after nephrectomy (surgical removal of a kidney), or after nephrectomy and resection of metastatic lesions. The FDA approval was based on data obtained from the Phase III KEYNOTE-564 trial, which included 994 patients with RCC who underwent nephrectomy and had intermediate-high risk, high-risk, or M1 no evidence of disease (M1 NED) RCC with clear cell component. In this trial, KEYTRUDA demonstrated significant improvements in disease-free survival (DFS) compared with placebo. The FDA has set 10 December this year as a Prescription Drug User Fee Act (PDUFA), or target action. Merck Research Laboratories clinical research vice president Scot Ebbinghaus said: “The acceptance of our application demonstrates the progress we are making in earlier lines and earlier stages of certain cancers across our oncology portfolio. “We look forward to working with the FDA towards the goal of bringing the first adjuvant immunotherapy option to appropriate patients with renal cell carcinoma in the U.S.” The company stated that the therapy in combination with axitinib is currently approved in the US, Japan and Europe for the first-line treatment for patients with advanced RCC.
美国食品药品监督管理局已批准默克公司对KEYTRUDA作为肾细胞癌患者辅助治疗的补充生物制品许可申请进行优先审查。 此前,今年3月,美国食品和药物管理局收到了该公司对KEYTRUDA的sBLA的完整回应信(CRL)。KEYTRUDA是一种反程序性死亡受体-1(PD-1)疗法。 sBLA允许在肾切除(手术切除肾脏)或肾切除和转移病灶切除后中、高或高复发风险的患者使用该疗法。 FDA的批准是基于III期KEYNOTE-564试验获得的数据,该试验包括994例接受肾切除并具有中高风险、高风险或M1无疾病证据(M1 NED)透明细胞成分的肾癌患者。 在这项试验中,与安慰剂相比,KEYTRUDA在无病存活率(DFS)方面有显著改善。 美国食品和药物管理局已经将今年12月10日定为处方药使用者费用法案(PDUFA),或目标行动。 默克研究实验室临床研究副总裁斯科特·艾宾豪斯(Scot Ebbinghaus)表示:“我们应用程序的接受表明,我们在肿瘤学产品组合中的某些癌症的早期系列和早期阶段取得了进展。 “我们期待着与美国食品和药物管理局合作,实现为美国合适的肾细胞癌患者提供第一种辅助免疫治疗选择的目标。” 该公司表示,该疗法与阿希替尼联合目前在美国、日本和欧洲被批准用于晚期肾癌患者的一线治疗。

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