2026-05-01 22:54（北京时间） / 路透社
路透社报道
2026年5月1日 22:54 UTC 更新于10分钟前
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2009年11月4日，美国食品药品监督管理局（FDA）的企业标识在马里兰州银泉市展示。路透社/杰森·里德 资料图片 购买授权许可，将打开新标签页
企业资讯
Revolution Medicines公司 关注
美国食品药品监督管理局 关注
5月1日（路透社）——Revolution Medicines公司周五表示，美国食品药品监督管理局已批准该公司的一款胰腺癌药物在获批前提前上市，供既往接受过治疗的患者使用。
美国FDA的早期准入计划允许患有严重或致命疾病的患者在药物获批前，无需参与临床试验即可使用试验性疗法。
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这款名为daraxonrasib的药物目前正在针对转移性胰腺导管腺癌（PDAC）患者进行研究，这类胰腺癌已扩散至身体其他部位，且患者已接受过其他疗法治疗。
Revolution Medicines公司在4月曾表示，在一项备受关注的后期临床试验中，daraxonrasib将胰腺癌患者的生存期延长了一倍，对比化疗效果显著，该消息推动公司股价大幅上涨。
这款药物还在其他后期临床试验中接受评估，其中包括针对非小细胞肺癌的试验。
Daraxonrasib还获得了FDA的优先审评券，该券旨在加快针对未被满足的医疗需求的药物研发和审评流程。
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Revolution Medicines表示，公司正努力在美国尽快启动早期准入项目，同时确保用药安全和公平性。
根据FDA规定，患者及其护理人员无法直接向该公司申请用药。Revolution Medicines称，申请必须由持有执照的主治医生提出。
帕德马纳班·阿南坦 班加罗尔报道；萨哈尔·穆罕默德 编辑
我们的准则：汤森路透信托原则。
US FDA authorizes early access to Revolution’s pancreatic cancer pill
2026-05-01 4:54 PM UTC / Reuters
By Reuters
May 1, 2026 4:54 PM UTC Updated 10 mins ago
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The corporate logo of the U.S. Food and Drug Administration (FDA) is shown in Silver Spring, Maryland, November 4, 2009. REUTERS/Jason Reed/File Photo Purchase Licensing Rights, opens new tab
Companies
Revolution Medicines Inc Follow
U.S. Food and Drug Administration Follow
May 1 (Reuters) – The U.S. Food and Drug Administration has authorized the granting of early access before regulatory approval to Revolution Medicines’ pill for patients with previously treated pancreatic cancer, the company said on Friday.
The regulator’s early access program allows patients with serious or life-threatening conditions to receive experimental treatments outside clinical trials before approval.
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The drug, daraxonrasib, is being studied in patients with metastatic pancreatic ductal adenocarcinoma (PDAC), a form of pancreatic cancer that has spread to other parts of the body, who have already been treated with other therapies.
Revolution said in April that daraxonrasib doubled the survival period in pancreatic cancer patients compared with chemotherapy in a closely watched late‑stage trial, sending the company’s shares sharply higher.
The pill is also being evaluated in other late-stage trials, including for non-small cell lung cancer.
Daraxonrasib has also received an FDA priority review voucher, which is intended to speed the development and review of drugs that address unmet medical needs.
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Revolution Medicines said it was working to open the early access program as quickly as possible in the U.S., while ensuring access is safe and equitable.
Under FDA rules, patients and caregivers cannot apply directly to the company for access. Requests must be made by a licensed treating physician, Revolution Medicines said.
Reporting by Padmanabhan Ananthan in Bengaluru; Editing by Sahal Muhammed
Our Standards: The Thomson Reuters Trust Principles.
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