来源：肿瘤资讯
近日，百时美重磅PD-1单抗Opdivo (nivolumab)在英国监管方面收获好消息，一贯以苛刻严厉而著称的英国医疗成本控制机构（NICE）改变了原来的意见，决定将该药物纳入指南，用于肾细胞癌的治疗。
NICE发布最终指南，最终决定将Opdivo (nivolumab)用于既往接受过治疗的成年肾细胞癌（RCC）患者，使得该药物成为英国肾细胞癌患者的“标准疗法”。
BMS向NICE提交的关键性III期临床试验数据显示：Opdivo和诺华的Afinitor相比，患者的生存期平均延长了5.4个月（25个月 VS 19.6个月）。BMS还表示，除了出色的治疗效果之外，Opdivo相较于常规疗法的不良反应也更少，显著地提升了患者的生活质量。英国目前约有900名晚期、不可治愈性的肾细胞癌患者，接下来的30天内，这部分患者还将继续接受CDF的资助，然后将由常规的NHS程序进行资助。
西旺斯大学肿瘤教授John Wagstaff指出，NICE这一决策的转变将为RCC患者带来新的希望。临床试验已经证明Nivolumab能够显著改善患者生存率，将该药物纳入医保后，希望英国未来RCC患者的生存率能够得到改善。过去的40年中，英国新增的肾癌患者人数翻倍，上涨了166%，这主要与人群的生活方式相关，如肥胖和抽烟等， 这就使得研发新的RCC药物成为强烈的需求。
作为肿瘤免疫疗法的领跑者，BMS的Opdivo已经在黑色素瘤、非小细胞肺癌、肾细胞癌、非霍奇金淋巴瘤等多种适应症中获批。今年7月份，NICE曾拒绝将Opdivo用于RCC，而这次态度上的转变，说明NICE认可Opdivo在治疗肾细胞癌方面的高效性以及性价比。
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原文：NICE u-turn backs Opdivo for kidney cancer
Kidney cancer patients are now likely to get access to Bristol-Myers Sqiubb's immunotherapy on the NHS in England and Wales after all, after cost regulators had a change of heart and recommended the drug as a cost-effective treatment option.
In a reversal of its draft decision, the National Institute for Health and Care Excellence has published a Final Appraisal Determination endorsing Opdivo (nivolumab) for adult patients with advanced renal cell carcinoma (RCC) after prior therapy, paving the way for 'routine' access to the first checkpoint inhibitor immunotherapy for this patient subset.
Data from a pivotal Phase III clinical study showed that patients who were treated with Opdivo after their previous therapy was no longer effective lived for an average of 5.4 months longer than those who received standard targeted therapy, Novartis' Afinitor (everolimus; 25 months versus 19.6 months, respectively). BMS said its drug also provided an improved quality of life as patients experienced fewer serious treatment-related side effects.
Around 900 patients in the advanced and incurable stages of this disease are likely to be treated with the drug each year, which will continue to be funded via the Cancer Drugs Fund until it is provided under normal NHS channels (in 30 days' time).
"This decision is a major turning point, which will bring a new wave of immunotherapy to kidney cancer patients," said Professor John Wagstaff, Professor of Medical Oncology, Swansea University.
"Nivolumab has demonstrated its potential to improve survival rates in clinical trials and NICE has now recognised the importance of achieving this for patients in England and Wales. This is an aggressive disease that is on the rise and new treatment options are vital to ensure that survival rates are improved in the coming years."
Over the last 40 years, the number of new patients diagnosed with kidney cancer each year has more than doubled, rising by 166 percent - mainly because of lifestyle factors such as obesity and smoking - highlighting the urgent need for new treatment options.
"We were very concerned with the initial news that NICE were not recommending the drug," said Nick Turkentine, chief executive of Kidney Cancer UK. "Data, personal statements, public opinion and various negotiations seem to have won the day and we could not be happier at this outcome for kidney cancer patients".
"The facts are there in the research, we have also spoken first-hand to patients who have been involved in trials and the benefits of making nivolumab available through the NHS are blindingly clear. This is a red letter day for kidney cancer patients; present and future."
"Nivolumab is a game-changing medicine that has demonstrated survival benefits in a number of cancer types and we are very happy that NICE has made this recommendation for patients with advanced kidney cancer and their families," said Benjamin Hickey, general manager, UK and Ireland, BMS.
"While this is a positive outcome for kidney cancer patients, it adds to the deepening cancer medicine disparity in the UK as those with lung cancer are still left without this innovative treatment option. Our goal is to make nivolumab available to everyone who could benefit from it and we urge NICE and NHS England to collaborate with us to find a swift solution for patients."
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