 First cancer 'living drug' gets go-ahead 首个癌症“活药”获许可 The US has approved the first treatment to redesign a patient's own immune system so it attacks cancer. 美国首个用重新设计病人免疫系统以治疗癌症的疗法已经获得许可。 The regulator - the US Food and Drug Administration - said its decision was a "historic" moment and medicine was now "entering a new frontier". 监管者美国食品与药物管理局称他们的决定是一个“历史性的”时刻，药物已经“进入一个新的领域”。 The company Novartis is charging $475,000 (£367,000) for the "living drug" therapy, which leaves 83% of people free of a type of blood cancer. Novartis公司现在的这个“活药”疗法要价是47万5千美元（相当于36万7千英镑），这可以使患血癌的83%的患者重获新生。 Doctors in the UK said the announcement was an exciting step forward. 在英国的医生说这一公告是激动人心的进步。 The living drug is tailor-made to each patient, unlike conventional therapies such as surgery or chemotherapy. 这种活药是针对每一位患者定制的，而不像传统的手术和化疗那样的疗法。 It is called CAR-T and is made by extracting white blood cells from the patient's blood. 它的名称是CAR-T，是用从患者血液中提取的白血细胞做成的。 The cells are then genetically reprogrammed to seek out and kill cancer. 这些细胞在基因上被重新变成，以去寻找并杀死癌细胞。 The cancer-killers are then put back inside the patient and once they find their target they multiply. 然后，这些经过编程后的癌症杀手被放回到患者体内，它们一旦发现目标，它们就进行繁衍。 'Enormously exciting' “异常地激动” Dr Scott Gottlieb, from the FDA, said: "We're entering a new frontier in medical innovation with the ability to reprogram a patient's own cells to attack a deadly cancer. 来自于FDA的Scott Gottlieb医生说：“在医学创新方面我们进入了一个新的领域，那就是我们有能力去重新排序患者自己的细胞以攻击致命的癌症。” "New technologies such as gene and cell therapies hold out the potential to transform medicine and create an inflection point in our ability to treat and even cure many intractable illnesses." “像基因和细胞疗法这样的新技术很有改变医学的潜力，甚至能为我们治疗和治愈许多顽固性的疾病的能力创造一个拐点。” The therapy, which will be marketed as Kymriah, works against acute lymphoblastic leukaemia. 这一在市场上将被称作Kymriah的疗法，会对急性淋巴细胞性白血病产生疗效。 Most patients respond to normal therapy and Kymriah has been approved for when those treatments fail. 一般的治疗方法对大多数患者有疗效，而一旦失败，Kymriah就派上了用场。 Dr Stephan Grupp, who treated the first child with CAR-T at the Children's Hospital of Philadelphia, said the new approach was "enormously exciting". StephanGrupp医生，作为在费城儿童医院对第一个孩子采用CAR-T疗法的人，说新的疗法让人“异常地激动。” "We've never seen anything like this before," he added. 他说：“此前我们从没有见过类似的事情。” That first patient had been near to death, but has now been cancer-free for more than five years. 这第一个患者当时接近死亡，但现在五年过去了已不见癌细胞。 Out of 63 patients treated with CAR-T therapy, 83% were in complete remission within three months and long-term data is still being collected. 在采用了CAR-T疗法的63名患者中，有83%的患者在三个月内痊愈并且长期追踪的数据还在收集中。 However, the therapy is not without risks. 但是，此疗法也存在风险。 It can cause potentially life-threatening cytokine release syndrome from the rapid proliferation of the CAR-T cells in the body. This can be controlled with drugs. 它可以导致由于体内的CAR-T细胞的快速增殖而产生的，潜在的，危及生命的细胞因子大量释放综合症。 New era 新时代 But the potential of CAR-T technology goes beyond one type of cancer. 但是CAR-T技术的潜力超过了一种癌症。 Dr David Maloney, medical director of cellular immunotherapy at the Fred Hutchinson Cancer Research Center, said the FDA's decision was a "milestone". DavidMaloney医生，是Fred Hutchinson癌症研究中心研究细胞免疫治疗的医疗主任。他说FDA的决定是个“里程碑”。 He added: "We believe this is just the first of what will soon be many new immunotherapy-based treatments for a variety of cancers. 他接着说：“我们相信这只是众多新的以免疫疗法为基础的，治疗各种癌症的方法的开始。” CAR-T technology has shown most promise against different blood-based cancers. CAR-T技术显示对不同血液系统癌症有着很大疗效。 However, it has struggled against "solid tumours" such as lung cancer or melanoma. 但是，它对于‘实体肿瘤“，如肺癌或黑色素瘤的医效并不佳。 Dr Prakash Satwani, a paediatric oncologist at Columbia University Medical, said: "The results haven't been that great when you compare it with acute lymphoblastic leukaemia, but I'm sure the technology will get better in the near future." PrakashSatwani医生是哥伦比亚大学医学部的儿科肿瘤专家，他说：“当你把它与急性淋巴细胞性白血病进行比较时，结果还不是很好，但我相信这项技术在不久的将来会变得更好。” Boosting the immune system is already a cornerstone of modern cancer treatment. 增强免疫系统已经成为当代治疗癌症的基础。 A range of drugs that "take the brakes off" the immune system to allow it to attack cancer more freely have already been adopted around the world. 在全世界范围内，一系列的免疫系统的药物使其能够更加自由的攻击癌症。 CAR-T technology, which goes a step further and redesigns the immune system, is at a much earlier stage. 而通过重新设计病人免疫系统的CAR-T技术，虽还在其发展的早期，却比现在的疗法向前跨了一大步。 Prof Peter Johnson, the chief clinician at the charity Cancer Research UK, said: "The first genetically modified cell therapy to be approved by the FDA is an exciting step forward. 英国癌症研究基金会的首席临床医生Peter Johnson教授说：“FDA批准的第一种转基因细胞疗法是一个令人兴奋的进步。 "We still have a lot to learn about how to use it safely and who might benefit from it, so it is important to recognise this is just a first step." “对于如何更安全使用这种方法以及对什么人有用，我们还有很多要学习的地方，所以要清醒地认识到这才只是刚开始。” |
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