2026年5月1日 / 美国东部时间下午3:14 / 哥伦比亚广播公司新闻
美国食品药品监督管理局(FDA)表示,将允许部分胰腺癌患者提前使用一款颇具前景的药物,无需等待其正式获批上市。
这款名为达拉妥雷沙(daraxonrasib)的药物每日需口服三次,它可以阻断促使癌细胞无限增殖的信号通路。制药商革命医药(Revolution Medicine)公布的临床试验数据显示,服用该药物的转移性胰腺癌患者中位生存期为13个月,而接受化疗的同类患者中位生存期仅约为6个月。
现年54岁的前参议员本·萨斯在接受《60分钟时事》采访时,将达拉妥雷沙称为“奇迹药物”,并表示该药帮助他延长了生存期,且疼痛症状有所缓解。
“与四个月前确诊时相比,我的疼痛已经大幅减轻,过去四个月里肿瘤体积更是缩小了76%之多,”萨斯在采访中告诉斯科特·佩利。
达拉妥雷沙将通过FDA的扩大准入计划上市,该计划也被称为“同情用药”,允许患有严重或晚期疾病的患者在临床试验之外使用在研疗法。FDA表示,此前接受过治疗且无其他可选方案的转移性胰腺导管腺癌患者,将有资格使用达拉妥雷沙。
革命医药于4月28日提交了扩大达拉妥雷沙使用范围的申请,FDA于4月30日批准了相关方案。FDA局长马蒂·马卡里表示,这一时间线“体现了FDA致力于为包括胰腺癌在内的严重且危及生命的疾病患者提供早期治疗途径的坚定承诺”。
“我曾接诊过众多转移性癌症患者,我希望今天的这项举措能够改善这类疾病患者的生活质量,”马卡里补充道。
美国国家癌症研究所预测,2026年全美将新增67530例胰腺癌确诊病例,同期将有52740人死于该病。尽管胰腺癌仅占新增癌症病例的3.2%,但其导致的死亡人数却占癌症总死亡人数的8.4%。根据该研究所的数据,胰腺癌的五年生存率约为13.7%,不过这一数据会因患者个体预后和治疗方案的不同而有所差异。
https://www.cbsnews.com/video/ben-sasse-clip-sunday-on-60-minutes/
FDA expands access to pancreatic cancer drug helping patients like Ben Sasse
May 1, 2026 / 3:14 PM EDT / CBS News
The Food and Drug Administration said it will allow some pancreatic cancer patients to receive access to a promising drug, even before it is officially approved for use.
The medication, daraxonrasib, is a pill taken three times a day. The drug blocks a signal that causes cancer cells to grow non-stop. Drugmaker Revolution Medicine reported that in a clinical trial, metastatic pancreatic cancer patients who took the drug survived a median of 13 months, compared to about six months for similar patients who underwent chemotherapy.
Former Sen. Ben Sasse, 54, called daraxonrasib “a miracle drug” in a conversation with “60 Minutes” and said it has helped him live longer and with less pain.
“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 Scott Pelley.
Daraxonrasib is being approved for use under the FDA’s expanded access program. Also called “compassionate use,” this option allows patients with serious or terminal conditions to take investigational therapies outside of a clinical trial. Patients with previously treated metastatic pancreatic ductal adenocarcinoma who have no other options will be eligible to receive daraxonrasib, the FDA said.
Revolution Medicine submitted the request to expand access to daraxonrasib on April 28. The FDA approved the protocol on April 30. FDA commissioner Marty Makary said the timeline “reflects the FDA’s strong commitment to facilitate early access to therapies for serious and life-threatening conditions, including pancreatic cancer.”
“Having taken care of many patients with metastatic cancer, I am hopeful that today’s action will improve the lives of patients suffering from this disease,” Makary added.
The National Cancer Institute predicts that 67,530 new cases of pancreatic cancer will be diagnosed in 2026, and that 52,740 people will die from the disease during the same time. Pancreatic cancer accounts for 8.4% of cancer deaths, despite making up only 3.2% of new cancer cases. It has a five-year survival rate of about 13.7%, according to the NCI, but that can vary depending on a person’s individual prognosis and treatment.
https://www.cbsnews.com/video/ben-sasse-clip-sunday-on-60-minutes/
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