2026-04-22 16:56:12 UTC / 路透社
作者：艾哈迈德·阿布勒埃因与普扬·辛格
2026年4月22日 世界标准时间下午4:56 更新于2小时前
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[1/3]美国卫生与公众服务部（HHS）部长小罗伯特·F·肯尼迪于4月22日在美国华盛顿国会山出席参议院卫生、教育、劳工与养老金委员会听证会，就美国总统唐纳德·特朗普向卫生与公众服务部提交的预算申请作证，……阅读更多
- 肯尼迪称FDA局长马卡里作出了不批准该药物的决定
- 《华尔街日报》社论呼吁撤换马卡里
- Replimune股价上涨15%
华盛顿4月22日路透电 — 美国卫生部长小罗伯特·F·肯尼迪在周三的参议院听证会上表示，他与美国食品药品监督管理局（FDA）驳回Replimune公司针对晚期皮肤癌的药物申请一事毫无关联，称该决定由该局局长马蒂·马卡里博士全权作出。
此次听证会旨在讨论特朗普政府2027财年卫生与公众服务部预算，肯尼迪在会上称“我与这项决定毫无关系”。
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本月早些时候，美国食品药品监督管理局拒绝批准Replimune公司的RP1药物，理由是该公司仅依靠单臂临床试验数据，未设置对照组。在驳回意见书中，FDA表示该公司必须提供来自设计完善的对照试验的数据，以证明其疗效的充分证据。
“这项决定由FDA作出，我们信任该局的流程。马蒂·马卡里告诉我，所有审查该药物的专家组均一致投票反对批准……因为该药物似乎并未生效，”肯尼迪说道。
自FDA两年内第二次驳回该药物申请以来，Replimune的股价已下跌近70%。
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不过，在周二晚间《华尔街日报》发表一篇称肯尼迪的说法不实的社论后，该公司股价在周三上涨了15%。
这篇社论将矛头指向FDA药品主管维奈·普拉萨德，普拉萨德此前曾因监管决策在《华尔街日报》受到批评。普拉萨德上月宣布将于4月离职。
社论援引参与该药物临床试验的癌症医生的话称，该药物确实有效。该报批评肯尼迪上周在国会山听证会上称马卡里“作出了不批准该药物的正确决定”。
社论称“以莫名其妙的理由剥夺患者获得救命药物的机会，是错误的变革方向。如果马卡里博士不明白这一点，那么FDA需要更换领导层。”
在4月10日被驳回申请后，Replimune表示其不同意FDA关于数据集是否足够获批的判定，并补充称FDA似乎与其在9月会议上的立场自相矛盾。
Replimune未立即回应置评请求。
负责监管FDA的卫生与公众服务部发言人安德鲁·尼克松表示：“FDA职业科学家和生物制品评估与研究中心的高级办公室领导层一致认定，（Replimune公司药物）当前的证据未达到监管批准所需的证据标准。”
普扬·辛格在班加罗尔、艾哈迈德·阿布勒埃因在华盛顿报道；卡罗琳·休默与比尔·伯克罗特编辑
我们的准则：路透社汤森路透信任原则。
US Health Secretary Kennedy distances himself from FDA’s Replimune cancer drug rejection
2026-04-22 16:56:12 UTC / Reuters
By Ahmed Aboulenein and Puyaan Singh
April 22, 2026 4:56 PM UTC Updated 2 hours ago
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[1/3]U.S. Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. arrives for a Senate Health, Education, Labor, and Pensions Committee hearing on U.S. President Donald Trump’s budget request for the Department of Health and Human Services on Capitol Hill in Washington, D.C., U.S., April 22,… Read more
- Kennedy says FDA Commissioner Makary made decision not to approve drug
- WSJ opinion piece calls for Makary to be replaced
- Replimune shares gain 15%
WASHINGTON, April 22 (Reuters) – Health Secretary Robert F. Kennedy Jr. told a Senate hearing on Wednesday that he had nothing to do with the U.S. FDA’s decision to not approve Replimune’s drug for advanced skin cancer, saying it was in the hands of the agency’s Commissioner Dr. Marty Makary.
Kennedy, at the hearing to discuss President Donald Trump’s budget for the Department of Health and Human Services for fiscal 2027, said he “had nothing to do with this decision.”
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Earlier this month, the Food and Drug Administration declined to approve Replimune’s drug, RP1, taking issue with the company’s reliance on a single‑arm study for the medicine without a control group. In its rejection letter, the agency said the company must provide data from a well-controlled trial demonstrating adequate evidence of effectiveness.
“This decision comes out of FDA, and we trust the process there. And I’ve been told by Marty Makary that every panel that looked at that drug unanimously voted against it… because it does not appear to work,” Kennedy said.
Replimune shares have fallen nearly 70% since the FDA’s rejection of the drug for the second time in two years.
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However, shares were up 15% on Wednesday following an opinion piece in The Wall Street Journal late on Tuesday that said Kennedy’s comments were not true.
It cast blame on the FDA’s drug head Vinay Prasad, who has come under fire before in the Journal for his regulatory decisions. Prasad said last month he would be leaving the agency in April.
The opinion piece cited cancer doctors who have worked on trials of the drug, saying it was effective. The paper called out Kennedy for saying at a Capitol Hill hearing last week that Makary “made the correct decision to not approve that drug.”
It said “denying patients a life-saving medicine for inexplicable reasons is the wrong kind of change. If Dr. Makary doesn’t understand that, the FDA needs a change in leadership.”
Replimune, following the April 10 rejection, said it disagreed with the FDA about whether the data set was sufficient for approval, adding that the agency appeared to have contradicted its positions expressed at a meeting in September.
Replimune did not immediately respond to a request for comment.
Andrew Nixon, spokesperson for HHS which oversees the FDA, said “FDA career scientists and senior office leadership in the Center for Biologics Evaluation and Research unanimously determined that the current evidence for (Replimune’s drug) does not meet the evidentiary standards required for regulatory approval.”
Reporting by Puyaan Singh in Bengaluru and Ahmed Aboulenein in Washington; Editing by Caroline Humer and Bill Berkrot
Our Standards: The Thomson Reuters Trust Principles.
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