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AstraZeneca’s (AZ) AKT inhibitor Truqap (capivasertib) has been recommended by the National Institute for Health and Care Excellence (NICE) as part of a combination treatment for advanced breast cancer. The health technology assessment agency has recommended in final draft guidance that the drug be used in combination with AZ’s endocrine therapy Faslodex (fulvestrant) to treat adults on the NHS in England and Wales with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer with at least one PIK3CA, AKT1 or PTEN gene alteration. Patients eligible for the therapy will also have experienced disease recurrence or progression after a CDK4/6 inhibitor plus an aromatase inhibitor. Approximately 56,800 new cases of breast cancer are diagnosed in the UK each year, and NICE estimates that around 1,100 patients will benefit from AZ’s combination. Given as a twice-a-day tablet, Truqap works by blocking the effects of proteins called ATK kinases, which allow cancer cells to grow and multiply. The Medicines and Healthcare products Regulatory Agency approved the combination in July 2024 after it was shown in the late-stage CAPItello-291 trial to reduce the risk of disease progression or death by 50% compared with Faslodex alone. NICE then requested further analyses from the company following its first committee meeting about the long-term effectiveness of Truqap compared with existing treatments. Helen Knight, director of medicines evaluation at NICE, said: “People with advanced breast cancer would value treatments like [Truqap] that can be given when limited options exist and because it may delay the need for chemotherapy and its associated side-effects. “We are therefore pleased the company has worked with us so that we are able to recommend this promising new treatment as a good use of NHS resources and value for money for taxpayers.” The science behind Truqap was discovered by AZ after a partnership with Astex Pharmaceuticals and collaboration with the Institute of Cancer Research (ICR) and Cancer Research Technology. Tom Keith Roach, president, AZ UK said: “[Truqap] is a UK-discovered medicine for eligible patients with advanced breast cancer. “The partnership between AZ, the ICR and Cancer Research Technology underscores the potential of UK life sciences, which we are working with [the] government to unlock on behalf of patients and the UK growth agenda.”

AstraZeneca (AZ) has received two separate recommendations from the National Institute for Health and Care Excellence (NICE) for use of its lung cancer drugs Tagrisso (osimertinib) and Imfinzi (durvalumab) in NHS patients across England and Wales. Tagrisso has been recommended for use as an adjuvant treatment following complete resection in adults with stage 1B to 3A non-small cell lung cancer (NSCLC) whose tumours express epidermal growth factor (EGFR) exon 19 deletions or exon 21 substitution mutations. Meanwhile, Imfinzi (durvalumab) has been recommended for use in combination with etoposide plus either carboplatin or cisplatin to treat adults with untreated extensive-stage small cell lung cancer (SCLC). Approximately 49,200 people are diagnosed with lung cancer in the UK every year. NSCLC is the most common form of the disease, accounting for around 85% of cases, while SCLC represents approximately 15% of all diagnoses. NICE’s decision on Tagrisso was based on positive results from the late-stage ADAURA trial, in which treatment with the drug after surgery reduced the relative risk of disease recurrence or death by 83% compared to placebo in patients with stage 2 to 3A EGFR-mutated NSCLC. Survival without disease recurrence at two years was 90% for the Tagrisso cohort and 44% for placebo and, among patients with stage 1B to 3A disease, 89% of those being treated with AZ’s drug were alive and disease-free at 24 months compared to 52% in the placebo group. Results from the phase 3 CASPIAN trial supported the health technology assessment agency’s recommendation of Imfinzi. A two-year follow-up analysis of the study showed that first-line treatment with Imfinzi plus platinum chemotherapy demonstrated significant and clinically meaningful improvements in overall survival in patients with extensive-stage SCLC versus chemotherapy alone, and updated results from the trial showed that the Imfinzi combination reduced the risk of death by 29% compared with chemotherapy alone at three years. Tom Keith-Roach, president, AZ UK, said: “This is fantastic news for lung cancer patients. We are proud that these decisions by NICE mean we’ve had 28 positive recommendations by NICE and the Scottish Medicines Consortium since 2021 across multiple cancer types and stages.” The latest recommendations come less than two weeks after the company’s Lynparza (olaparib) was recommended by NICE to treat adults with HER2-negative, locally advanced or metastatic breast cancer with germline BRCA1 or BRCA2 mutations after chemotherapy.

近年来，随着司美格鲁肽的红火，借司美格鲁肽之名违规销售假药的犯罪事件也愈演愈烈。 近期，路透社就分享了一个很有趣的案例： 来自德州，现年36岁的德鲁想要买Ozempic（司美格鲁肽的糖尿病商标）用于减肥，但又嫌弃美国药太贵，想买点便宜的，因此就驱车400公里前往墨西哥买药，买来后他检查了一下注射笔，感觉注射笔有点奇怪，因此就分享在了社交媒体红迪上。 几位网友的评论让他意识到了这大概率是假货。 “看起来像是胰岛素”。 如果真的是胰岛素的话，那么德鲁万一真的服药可能就危险了，过量胰岛素会导致血糖急剧下降，可能导致头晕癫痫，甚至死亡。 那这批假药是怎么来的呢？ MP5B060批次 一般而言，诺和诺德会在包装上印有字母和数字的组合来验证药物批次，然后使用这些药物在给定国家/地区跟踪产品。 而德鲁购买的假笔带有一项批次编号MP5B060，骗子们特意加上编号来让它们看起来显得真实。而对于诺和诺德来说，这一批次意味着这是一批运往埃及的司美格鲁肽。 而德鲁显然不应该在远隔半个地球的墨西哥买到这一批次的药物。 根据路透社对药品监管机构公告和通过《信息自由法》要求获得的文件的审查，到德鲁购买时，批次为MP5B060的假药已经出现在从阿塞拜疆到北马其顿的至少10个国家。 世界卫生组织（WHO）也于2023年7月发布了关于批号为MP5B060的产品的警告，国际刑警组织去年也警告说，胰岛素注射笔正在被重新贴标签和重新包装，使其看起来像 Ozempic。因此，一些国家/地区甚至禁止使用带有该编号的产品。 例如在去年1月时，阿塞拜疆卫生部下辖机构专门发布公告来教人如何辨别假药和真药。比如说假药的说明书仅有英文，原厂地写的是埃及，而真药的说明书同时兼有阿塞拜疆语和英语，原产地写的是丹麦。 注射笔的颜色也是德鲁所阐述事实中的一环，可以明显看到左边假冒产品的蓝色更深，笔身相对更细，而右边真品的蓝色相对更淡一些，笔身更粗。 实际上，假冒伪劣者采用的是赛诺菲的胰岛素笔 Apidra Solostar，装在预包装的蓝色自动注射器中，带有类似于 Ozempic 的夹盖。因此可以做到以假乱真的效果。 实际上MP5B060这批假药采用的就是 Apidra Solostar+包装盒的组合。 简单对比的话，赛诺菲的胰岛素笔在美国境外成本只需要8.81美元/支，而根据德鲁所述，他一开始咨询药房，药房告诉他司美格鲁肽的价格是200美元，但等到他去线下购买时，发现最低也需要350美元（美国司美格鲁肽月花费约1000美元）。 价格过高显然让德鲁难以接受，当他听说在墨西哥边境小镇Nuevo Progreso可以以更低的价格买到这种药物，他就立刻前往了。 当然，跨境携带处方药进入美国是刑事犯罪。 在路透社的报道中，德鲁要求只透露自己的名字，他说他没有使用这些注射笔，也没有向当局报告购买情况，更没有将产品送去检测。 当然德鲁的案例主要说明的是MP5B060批次上的问题，这说明许多批发商大概率是从同一个渠道获得了这批假药，可能是同一渠道的还有发现于危地马拉的MP5A370和MP5D600，除了MP系列批次，还有一些其他批次上的假冒问题，可能来源于其他渠道。 NAR0074批次 和上文中提到的胰岛素笔+假包装盒的组合不同，NAR0074批次的假冒产品用的是真司美格鲁肽+假针头的组合。这是今年6月份WHO通报的三起批次之一，NAR0074批次发生在美国，LP6F832发生在巴西，MP5E511发生在欧盟。 NAR0074的发现源自于诊所对分销商的验货上。 诊所负责人需要检查分销商F.M. Howell带来的司美格鲁肽，F.M. Howell虽然是成立了一百多年的老牌分销商，但是负责人留了个心眼，没因为对方品牌大就放心，还是找了第三方机构兼分销商竞争对手去检测。 送去实验室检查后意外地发现，司美格鲁肽成分确实没问题，但是剂量略有超标。 仔细观察下，第三方检测人员还注意到了其他的不规则现象:注射针头看起来略有不同。每支钢笔上的一个小标签几乎察觉不到是歪的。 而当第三方仔细检查序列号时，发现理应该有排序序列号，竟然清一色是430834149057。第三方检测机构立刻将这件事报道给了诺和诺德，三天后FDA就出示了专门针对430834149057序号NAR0074批次的警告，针头是假冒的，无菌性未知，标签贴错了，应该是NovoFine Plus而不是NovoFine。 诺和诺德方面的人员称，NAR0074批次其他序号的应该是没问题的，只有430834149057序号有问题。 但是追查源头，似乎也是个无头案。老牌分销商F.M. Howell方面因为保密协定拒绝回应来源。 MP5E511批次 MP5E511批次和MP批次类似，也是采用胰岛素+假包装的组合，在德国的调查重点在于德国批发商Pharma Medtec。后续的发现就类似于套娃式的层层转包。 据称，向Medtec制药公司销售假药的奥地利经销商之一是Styria的AZ Naturemed。 经销商AZ Naturemed还被指控直接向英国的一家批发商销售了300包假冒Ozempic，而从AZ公司后，又追溯到了另外一家分销商Neusser Firma。 后续警方发现这似乎能追溯到土耳其，Neusser Firma和AZ Naturemed都从土耳其安卡拉的AUB医疗保健公司获得了假冒产品。 总结 总的来说，针对目前的假药问题仍然是一项尖锐的挑战，竞争对手礼来的替尔泊肽也已经出现了类似的情况。考虑到未来更多竞争者加入赛道，假药的横行可能成为制药商们需要重点应对的对象。