更新时间：2026年3月25日 / 美国东部时间上午6:09 / CBS/美联社
华盛顿 — 联邦卫生官员周二发布警告，谴责生物技术亿万富翁Patrick Soon-Shiong博士近期在播客中声称其公司的膀胱癌药物可能能够治疗、治愈甚至预防其他类型癌症的言论具有误导性。
美国食品药品监督管理局（FDA）发出的警告信对一则电视广告和一期单独的播客节目提出质疑，这两则内容均在推广ImmunityBio公司的主要产品Anktiva。该制药公司是Soon-Shiong收购的多家生物技术公司之一，而Soon-Shiong还拥有《洛杉矶时报》。
信中指出：“FDA已确定电视广告和播客内容存在虚假或误导性陈述……此外，电视广告和播客内容显示Anktiva被用于其未获批准的新用途，且其药品标签未提供充分的使用说明。”
FDA警告信发布后，ImmunityBio股价在周二交易中暴跌超过21%，收于7.42美元。
Anktiva于2024年获FDA批准用于治疗一种难以治愈的膀胱癌。ImmunityBio一直在寻求FDA批准，将该药物的适用范围扩大至多种其他适应症，包括肺癌和胰腺癌等。
Soon-Shiong具有争议性的言论出现在1月份的《肖恩·斯派塞秀》（The Sean Spicer Show）播客节目中，该节目主题为“FDA是否在阻碍救命的癌症治疗？”
在采访中，Soon-Shiong一度称其公司的药物是“可能治愈癌症的最重要分子”。几分钟后，身兼公司执行董事长和首席医疗官的Soon-Shiong表示，尽管该药物仅获批用于膀胱癌，但“实际上它可以治疗所有癌症”。
在节目稍后部分，他还声称：“如果你接触过辐射，我们有预防癌症的疗法，那就是Anktiva。”
FDA监管人员表示，这些陈述违反了联邦药品营销规定，因为它们“造成了对该药物的误导性印象”。
监管机构还指出，该播客未包含任何关于药物风险和副作用的信息，其中可能包括尿路感染、疼痛、寒颤和发热。根据FDA法律规定，药品推广必须平衡展示药物的风险与益处。
FDA的警告信直接发给了ImmunityBio首席执行官Richard Adcock，同时也对Anktiva的一则电视广告提出了类似担忧。无论是广告还是播客，均将该公司药物描述为“癌症疫苗”，而FDA称这一说法不实。
该公司需在15天内纠正问题，并书面回复FDA其合规计划。截至周二下午，ImmunityBio网站上已移除了该播客的链接。
总部位于加利福尼亚州卡尔弗城的ImmunityBio发言人Sarah Singleton通过电子邮件表示，公司“非常重视”FDA的警告，并计划“与该机构合作，处理信件中提出的问题”。
在特朗普政府时期，FDA加强了对制药商以及在线药房的警告，包括针对公司高管在电视节目和播客中露面的监管。
FDA warns manufacturer that billionaire’s claims about cancer drug Anktiva are misleading
Updated on: March 25, 2026 / 6:09 AM EDT / CBS/AP
Washington — Federal health officials posted a warning Tuesday about misleading statements made by biotech billionaire Dr. Patrick Soon-Shiong, who recently told podcast listeners his company’s bladder cancer drug may be able to treat, cure or even prevent other types of cancers.
The warning letter from the Food and Drug Administration takes issue with a TV advertisement and a separate podcast episode promoting Anktiva, the lead product of ImmunityBio Inc. The drugmaker is one of several biotech firms acquired by Soon-Shiong, who also owns the Los Angeles Times.
The “FDA has determined that the TV ad and podcast are false or misleading,” the letter says. … “Furthermore, the TV ad and podcast provide evidence that Anktiva is intended for new uses for which it lacks approval, and for which its labeling does not provide adequate directions for use.”
Company shares fell more than 21% in Tuesday trading to close at $7.42 after the FDA letter was posted online.
Anktiva was approved by the FDA in 2024 for patients with a hard-to-treat form of bladder cancer. ImmunityBio has been working to win FDA approval to expand the drug’s use to a number of other conditions, including forms of lung and pancreatic cancer.
Soon-Shiong’s controversial statements came during a January episode of “The Sean Spicer Show” podcast titled “Is the FDA blocking life-saving cancer treatments?”
At one point during the interview, Soon-Shiong described his company’s drug as “the most important molecule that could cure cancer.” A few minutes later, Soon-Shiong, who is the company’s executive chairman and chief medical officer, said that while the drug is approved for bladder cancer, “it actually can treat all cancers.”
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Later in the episode he said, “We have the therapy to prevent cancer if you were exposed to radiation, and that’s Anktiva.”
FDA regulators said the statements violate federal drug marketing rules because they “create a misleading impression” of the drug.
Regulators also noted that the podcast didn’t contain any information about risks and side effects of the drug, which can include urinary tract infections, pain, chills and pyrexia. Under FDA law, drug promotions are required to give a balanced view of a drug’s risks and benefits.
The FDA warning, addressed to ImmunityBio CEO Richard Adcock, raises similar concerns with a TV advertisement for Anktiva. Both the ad and the podcast refer to the company’s drug as a “cancer vaccine,” which the FDA said is false.
The letter gives the company 15 days to correct the problems and respond to the agency in writing about its plans to comply. By Tuesday afternoon, a link to the podcast had been removed from ImmunityBio’s website.
Sarah Singleton, spokesperson for Culver City, California-based ImmunityBio, said via email that the company takes the FDA’s warning “very seriously” and plans to “work cooperatively with the agency to address the matters raised in the letter.”
Under the Trump administration, the FDA has stepped up warnings against drugmakers as well as online pharmacies, including appearances by company executives on TV shows and podcasts.
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