2026年8月26日 / 美国东部时间晚7:02 / 哥伦比亚广播公司/美联社
美国食品药品监督管理局周三批准了一款针对晚期胰腺癌的突破性新药，为美国患者提供了一种对抗这种最致命癌症类型之一的更有效治疗方案。
FDA官员对这款名为daraxonrasib的首创口服药物给予了加速批准，该药物可阻断一种突变蛋白，这种蛋白会推动超过90%的胰腺癌病例的肿瘤生长。此前数十年来，制药厂商一直未能找到这类治疗方法。
这款每日服用的药片将由Revolution Medicines公司以商品名Rasonque上市销售。该公司宣布，一个月的药量售价约为39800美元。
在一项将患者随机分配接受试验性治疗或标准化疗的研究中，服用该药物的患者生存期几乎翻倍，且严重副作用更少。这项由公司资助的研究招募了500名转移性（即癌细胞已扩散）癌症且对先前治疗无反应的患者。
“大多数胰腺癌患者确诊时已为时过晚，此时癌症已发生转移，已经扩散，”哥伦比亚广播公司新闻医疗记者塞琳·贡德里博士说道。“……这款药片可以阻断一种名为RAS的蛋白质，RAS突变驱动了约90%的胰腺癌病例。在过去40年里，科学家们一直将RAS称为‘不可成药靶点’，而现在我们终于拥有了针对它的药物。”
接受新治疗的患者中位生存期为13.2个月，而接受化疗的患者中位生存期为6.7个月。该药物的副作用包括皮疹、口腔溃疡、腹泻及其他消化问题。
“这是我所能想到的最受期待的批准之一，”弗雷德·哈钦森癌症中心的安德鲁·科维勒博士说道。“这种药物并非治愈方法，但却是一项重大进步。”
胰腺癌是最致命的癌症类型之一，主要原因是很难在癌细胞扩散至其他器官之前确诊。美国癌症协会估计，今年美国将有约6.7万例新增胰腺癌病例，超过5.2万人将死于这种疾病。其整体五年生存率仅为13%。
内布拉斯加州前参议员本·萨斯于去年12月被诊断出患有四期胰腺癌，他在今年4月接受《60分钟》采访时表示，自己参与了daraxonrasib的临床试验。萨斯称该药物对他效果极佳，将其称为“神药”。
“我现在的疼痛比四个月前确诊时轻多了，而且在过去四个月里，我的肿瘤体积大幅缩小了76%，”萨斯告诉《60分钟》节目组。
萨斯表示，他在去年12月确诊时，医生预估他的生存期仅有“三到四个月”。
“我现在已经远超这个时间了，”他说道。
FDA监管机构周三指出，他们比原定目标日期提前了六个多月批准了这款药物。
“我们的根本职责是尽快为患者提供更多治愈方法和有意义的治疗方案，”FDA代理专员凯尔·迪亚曼塔斯在一份声明中说道。
与其他已有多种化疗替代方案的癌症不同，胰腺癌一直更难攻克。
这款新药靶向通常调节细胞生长的RAS基因家族的突变。KRAS突变尤其在推动胰腺癌发展方面起着关键作用。但由于突变蛋白的特殊结构使得药物难以附着，这种癌症驱动因素长期以来被认为“不可成药”。
治疗胰腺癌的医生希望，这款药物可能为其他癌症类型带来更多新的治疗选择，目前已有数十款同类试验药物正在研发中。
“我认为这为许多其他公司打开了大门，”加州希望之城橙县分院的帕什通·卡西博士说道。“我认为后续将会有更多试验针对这种治疗方法在其他肿瘤类型中的应用展开。”
Revolution Medicines公司的药物本质上利用一种分子胶与多种KRAS亚型结合。这家位于加州雷德伍德城的制药商正在研究其技术在包括肺癌在内的其他多种癌症中的应用。
FDA approves new pancreatic cancer drug that could extend patients’ lives
August 26, 2026 / 7:02 PM EDT / CBS/AP
The Food and Drug Administration on Wednesday approved a groundbreaking new drug for advanced pancreatic cancer, offering U.S. patients a more effective treatment against one of the deadliest types of cancer.
FDA officials gave expedited approval to the first-of-a-kind pill, called daraxonrasib, which blocks a mutated protein that fuels tumor growth in more than 90% of pancreatic cancer cases. It’s an approach that previously eluded drugmakers for decades.
The daily pills will be sold by Revolution Medicines under the brand name Rasonque. A one-month supply would cost approximately $39,800, the company announced.
Patients taking the drug nearly doubled their survival time, with fewer severe side effects, in a study that randomly assigned them to receive the experimental treatment or more chemotherapy. The company-funded study enrolled 500 patients whose metastatic, or spreading, cancer had quit responding to prior treatment.
This photo provided by Revolution Medicines on Aug. 26, 2026, shows packaging for the new pancreatic cancer drug, daraxonrasib, under the brand name Rasonque. Revolution Medicines via AP
“Most patients get the diagnosis of pancreatic cancer quite late, at which point its already metastatic, it’s already spread,” said Dr. Céline Gounder, CBS News medical correspondent. “… This is a pill that blocks a protein called RAS, and mutations in RAS drive around 90% of all pancreatic cancers. Scientists have been calling RAS ‘undruggable’ for the last 40 years, and now finally, we have a drug for it.”
Patients getting the new treatment lived for a median of 13.2 months compared with 6.7 months for chemotherapy recipients. Side effects included skin rash, mouth sores, diarrhea and other digestive issues.
“This is one of the most anticipated approvals I can think of,” said Dr. Andrew Coveler of the Fred Hutch Cancer Center. “This medicine is not a cure but a significant improvement.”
Pancreatic cancer is among the most deadly forms in large part because it is hard to detect before it starts spreading to other organs. The American Cancer Society estimates about 67,000 new cases will be diagnosed in the United States this year and more than 52,000 people will die from the disease. The five-year overall survival rate is 13%.
Former Sen. Ben Sasse of Nebraska, who was diagnosed with stage-four pancreatic cancer last December, told “60 Minutes” in April that he was part of the clinical trial for daraxonrasib. Sasse said the drug had been extremely effective for him, describing it as a “miracle drug.”
“I have much, much less pain than I had four months ago when I was diagnosed, and I have a massive 76% reduction in tumor volume over the last four months,” Sasse told “60 Minutes.”
Sasse said that when he was diagnosed in December, doctors had given him a “three- to four-month life expectancy.”
“I am on extended time already,” he said.
FDA regulators noted on Wednesday that they approved the drug more than six months ahead of their target date.
“It is our fundamental duty to deliver more cures and meaningful treatments to patients as quickly as possible,” the FDA’s acting commissioner, Kyle Diamantas, said in a statement.
Unlike with other cancers that have benefited from a variety of chemotherapy alternatives, pancreatic cancer has been harder to tackle.
The new drug targets mutations in the RAS gene family that normally regulates cell growth. What are known as KRAS mutations are especially critical in fueling pancreatic cancer. But a structure that made it hard for drugs to stick to the mutated proteins meant this cancer driver was long considered “undruggable.”
Doctors who treat pancreatic cancer hope the drug may usher in more new options for other forms of cancer, with scores of experimental drugs in development.
“I think this has opened doors for many other companies,” said Dr. Pashtoon Kasi of City of Hope Orange County, a California-based cancer center. “Downstream I think there are going to be a lot more trials looking at this approach in other tumor types.”
Revolution Medicines’ drug uses what’s essentially a molecular glue to bind with multiple KRAS subtypes. The Redwood City, California-based drugmaker is studying its technology for several other forms of cancer, including lung cancer.
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