{"id":90989,"date":"2026-05-05T19:02:40","date_gmt":"2026-05-05T19:02:40","guid":{"rendered":"https:\/\/diyhaven858.wasmer.app\/index.php\/expanded-access-to-daraxonrasib-signals-dawn-of-a-new-era-in-pancreatic-cancer-treatment\/"},"modified":"2026-05-05T19:02:40","modified_gmt":"2026-05-05T19:02:40","slug":"expanded-access-to-daraxonrasib-signals-dawn-of-a-new-era-in-pancreatic-cancer-treatment","status":"publish","type":"post","link":"https:\/\/diyhaven858.wasmer.app\/index.php\/expanded-access-to-daraxonrasib-signals-dawn-of-a-new-era-in-pancreatic-cancer-treatment\/","title":{"rendered":"Expanded access to daraxonrasib signals \u2018dawn of a new era\u2019 in pancreatic cancer treatment"},"content":{"rendered":"<p> <br \/>\n<\/p>\n<div data-component=\"ArticleContent\">\n<div class=\"article__below-title\">\n<div class=\"mobile-trust-box\">\n<div class=\"row\">\n<div class=\"col-12 col-md-5 d-xl-none\">\n<div class=\"trust-box\">\n<div class=\"trust-box-logo d-none d-md-block\">\n            <img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.healio.com\/~\/media\/h5\/feature\/news\/publogos\/hot.svg?la=en&amp;h=24&amp;w=141&amp;hash=2F86D471C8514C0E334E329AA799E8B4\" class=\"logo-img\" height=\"24\" alt=\"hemonc today logo\" width=\"141\"\/>\n          <\/div>\n<\/p><\/div>\n<\/p><\/div>\n<div class=\"col-12 col-md-6 offset-md-1 offset-xl-0 col-xl-12\">\n<div class=\"email-alert-button-wrapper d-none\" data-component=\"EmailTopicAlert\" data-module=\"Subspecialty Email Topic Alerts Top\" data-manage-email-link=\"\/footer\/account-information\/my-account\/email-subscriptions-and-alerts#emailAlerts\">\n  <hidden data-setting-item=\"d265901d-6d37-49c7-a8f6-c7bf19a02509\"\/><br \/>\n  <hidden data-crm-source=\"Subspecialty Topic Alert\"\/><\/p>\n<div class=\"email-alert-button d-none\" data-topic-button=\"not-subscribed\">\n<p>&#13;<br \/>\n      <span data-module-track-action=\"Email Alerts TOP_Click_Healio News Article\" data-module-track-label=\"Email Alerts TOP_Healio News Article\">&#13;<br \/>\n        <i class=\"fas fa-plus-circle\"\/>&#13;<br \/>\n        Add topic to email alerts&#13;<br \/>\n      <\/span>&#13;\n    <\/p>\n<div class=\"email-alert-inner collapse u4d40b438b92448f0ae60ae3fa76a3205\">\n<div class=\"email-alert-dialogue\">\n<p>&#13;<br \/>\n          Receive an email when new articles are posted on <span data-content=\"topic-title\"\/>&#13;\n        <\/p>\n<div class=\"d-none\" data-sign-up-type=\"unknown\">\n          Please provide your email address to receive an email when new articles are posted on <span data-content=\"topic-title\"\/>.<\/p><\/div>\n<\/p><\/div>\n<p>      <button type=\"button\" class=\"btn btn-primary\" data-loading-text=\"Loading &lt;i class=\" fa=\"\" fa-spinner=\"\" fa-spin=\"\">&#8220;&#13;<br \/>\n              data-action=&#8221;subscribe&#8221;&gt;&#13;<br \/>\n        Subscribe&#13;<br \/>\n      <\/button>\n    <\/div>\n<\/p><\/div>\n<div class=\"d-none\" data-topic-modal=\"failed\">    <strong>We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.<\/strong>  <\/p>\n<p><button data-dismiss=\"modal\" class=\"btn btn-primary btn-lg btn-block\">Back to Healio<\/button><\/p>\n<\/div>\n<\/div><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/div>\n<h2>Key takeaways:<\/h2>\n<ul>\n<li>The FDA authorized expanded access to daraxonrasib for patients with pretreated metastatic pancreatic cancer.<\/li>\n<li>Its manufacturer can provide the drug to eligible patients for free while regulatory review continues.<\/li>\n<\/ul>\n<p>      <b>Suneel Kamath<\/b><b>, MD,<\/b> knows too well the sense of helplessness that comes with living through what he calls \u201cthe doughnut hole.\u201d<\/p>\n<p>After compelling data from a late-stage trial are presented at a major medical meeting or published in a peer-reviewed journal, excitement about a potentially practice-changing treatment spreads like wildfire through the clinical community and the findings support a new drug application to the FDA.<\/p>\n<figure class=\"figure article__og-image\">&#13;\n    <picture>&#13;<source srcset=\"https:\/\/www.healio.comhttps:\/\/www.healio.comhttps:\/\/www.healio.com\/~\/media\/slack-news\/hemonc\/misc\/infographics\/hot-infographics\/2026\/05_may\/hot0526daraxonrasib_graphic_01.webp?w=476\" media=\"(max-width: 768px)\">&#13;<source srcset=\"https:\/\/www.healio.com\/~\/media\/slack-news\/hemonc\/misc\/infographics\/hot-infographics\/2026\/05_may\/hot0526daraxonrasib_graphic_01.webp?w=800\" media=\"(max-width: 992px)\">&#13;<source srcset=\"https:\/\/www.healio.com\/~\/media\/slack-news\/hemonc\/misc\/infographics\/hot-infographics\/2026\/05_may\/hot0526daraxonrasib_graphic_01.webp?w=595\" media=\"(max-width: 1200px)\">&#13;<source srcset=\"https:\/\/www.healio.comhttps:\/\/www.healio.comhttps:\/\/www.healio.com\/~\/media\/slack-news\/hemonc\/misc\/infographics\/hot-infographics\/2026\/05_may\/hot0526daraxonrasib_graphic_01.webp?w=476\" media=\"(min-width: 1200px)\">&#13;<source srcset=\"https:\/\/www.healio.comhttps:\/\/www.healio.comhttps:\/\/www.healio.com\/~\/media\/slack-news\/hemonc\/misc\/infographics\/hot-infographics\/2026\/05_may\/hot0526daraxonrasib_graphic_01.webp?w=476\">&#13;<br \/>\n&#13;<br \/>\n      <img decoding=\"async\" src=\"https:\/\/www.healio.com\/~\/media\/slack-news\/hemonc\/misc\/infographics\/hot-infographics\/2026\/05_may\/hot0526daraxonrasib_graphic_01.jpg?w=800\" alt=\"Quote from Suneel Kamath, MD\" class=\"figure-img img-fluid\" width=\"800\"\/>&#13;<br \/>\n    <\/source><\/source><\/source><\/source><\/source><\/picture>&#13;<figcaption class=\"figure-caption\">&#13;<br \/>\n      &#13;<br \/>\n    <\/figcaption>&#13;<br \/>\n  <\/figure>\n<p>Then, a monthslong wait begins.<\/p>\n<p>\u201cDuring this time, the trials are all closed, the drug is not on the market and nobody can get it,\u201d Kamath, a gastrointestinal oncologist at Cleveland Clinic, told Healio. \u201cYou tell your patients, \u2018The therapy should be available by this time next year. As soon as it is, I\u2019m going to give it to you, but I can\u2019t give it to you today.\u2019 It\u2019s a terrible feeling.\u201d<\/p>\n<p>The delay is most agonizing when the treatment under regulatory review is intended for people with a particularly lethal disease.<\/p>\n<p>That explains the emotions Kamath felt \u2014 surprise, excitement and relief among them \u2014 when he learned the FDA would allow patients with pretreated metastatic pancreatic cancer to receive daraxonrasib (RMC-6236, Revolution Medicines) under an expanded access protocol (EAP).<\/p>\n<p>Topline data from a randomized phase 3 trial showed the investigational oral medication doubled survival in this setting compared with standard second-line chemotherapy.<\/p>\n<p>\u201cWith some diseases, lifespans are measured in years,\u201d Kamath said. \u201cTime certainly still matters, but most likely we have other viable treatment options. We can\u2019t say that for pancreatic cancer. Many of the people we are treating today may not be alive when the next therapy is approved. If time is of the essence for any disease, it\u2019s this one. When we know a drug really works, it is very difficult to educate our patients about why we can\u2019t use it. To have the ability to offer the right treatment at the right time for our patients is amazing.\u201d<\/p>\n<h2>\u2018This is not hyperbole\u2019<\/h2>\n<p>Most pancreatic ductal adenocarcinoma (PDAC) cases are diagnosed at advanced stages due to absence of symptoms with early disease and lack of early detection strategies.<\/p>\n<p>Only 13% of patients with PDAC \u2014 and 3% of those with distant disease \u2014 survive 5 years, according to American Cancer Society statistics.<\/p>\n<p>Multiagent chemotherapy is standard, conferring median survival of less than a year in the first-line setting and about 6 months in the second line.<\/p>\n<p>Daraxonrasib is an oral pan-RAS inhibitor in development for treatment of advanced solid tumors.<\/p>\n<p>      <i>RAS<\/i> mutations \u2014 particularly those in the <i>KRAS<\/i> gene \u2014 are found in more than 90% of pancreatic cancers. Although long known to be the key driver in disease development and progression, no therapy has successfully been able to target them.<\/p>\n<p>The randomized phase 3 RASolute 302 trial included about 500 adults with previously treated PDAC. Some harbored <i>RAS<\/i> variants and others had no identified <i>RAS<\/i> mutations.<\/p>\n<p>Investigators assigned trial participants to 300 mg daraxonrasib daily or investigator\u2019s choice of standard IV cytotoxic chemotherapy (gemcitabine\/nab-paclitaxel, FOLFOX or liposomal irinotecan plus 5-FU).<\/p>\n<p>Results from a first interim analysis of the entire study population showed a near-doubling of OS in the daraxonrasib group (median, 13.2 months vs. 6.7 months; HR = 0.4; <i>P<\/i> &lt; .0001). The trial met all other prespecified primary and secondary endpoints, including PFS, objective response and patient-reported quality of life. The most common toxicities observed in the trial included skin rashes, GI toxicities and mucositis.<\/p>\n<p>\u201cWe use a lot of hyperbole in oncology,\u201d Kamath said in an interview. \u201cTerms like \u2018breakthrough\u2019 and \u2018game changer\u2019 are overused big time. This is not hyperbole. To have an incredibly effective drug that takes down a terrible target that is present in more than 90% of pancreatic cancers truly is a game-changing step forward.\u201d<\/p>\n<p>Last fall, the FDA included daraxonrasib in its Commissioner\u2019s National Priority Voucher pilot program. The pathway accelerates review of products that align with one of five specified national health priorities, such as meeting a large unmet medical need. A decision on approval is expected at some point this year.<\/p>\n<p>On May 1 \u2014 about 2 weeks after Revolution Medicines issued topline data from its interim analysis \u2014 the FDA issued a \u201csafe to proceed\u201d letter allowing the company to initiate an EAP for daraxonrasib. Under the protocol, Revolution Medicines can supply the drug at no cost to eligible patients with previously treated metastatic PDAC.<\/p>\n<p>\u201cRevolution Medicines commends the FDA\u2019s expedited review and continued commitment to providing a pathway for patients with life-threatening diseases to access investigational therapies outside of a clinical trial when no comparable or satisfactory alternative treatment options are available,\u201d a company press release stated. \u201cThis authorization represents a critical step in the process of opening an EAP. Revolution Medicines is moving as quickly as possible to ensure safe and equitable access to daraxonrasib for eligible patients in the United States.\u201d<\/p>\n<p>Licensed physicians must initiate all requests for expanded access to daraxonrasib on behalf of their patients.<\/p>\n<h2>\u2018A paradigm shift\u2019<\/h2>\n<p>The enthusiasm surrounding daraxonrasib had been building long before Revolution Medicines issued its topline data announcement last month.<\/p>\n<p>Kamath, who submitted his first request for expanded access 3 days after the FDA cleared the way, began hearing inquiries from patients about the drug last fall.<\/p>\n<div class=\"mug left\"><img decoding=\"async\" alt=\"Andrew L. Coveler, MD\" style=\" height:106px; width:80px\" src=\"https:\/\/www.healio.com\/~\/media\/slack-news\/hemonc\/mugs\/c\/coveler_andrew_2025_.jpg\"\/><\/p>\n<p><strong><b>Andrew L. <\/b><b>Coveler<\/b><\/strong><\/p>\n<\/div>\n<p>\u201cIt has been on a lot of people\u2019s radar for a long time,\u201d <b>Andrew L. <\/b><b>Coveler<\/b><b>, MD,<\/b> director of the pancreatic cancer specialty clinic at Fred Hutch Cancer Center, told Healio. \u201cThis is the first of what hopefully will be many RAS inhibitors but, because this is the furthest along, many patients have been following it. If they hadn\u2019t found out about it on their own, one of their family members had told them.<\/p>\n<p>\u201cYou can imagine the stress they feel when they know this drug is coming \u2014 even before what amounted to unprecedented results from the phase 3 trial \u2014 but they can\u2019t get it,\u201d Coveler added. \u201cThat is incredibly difficult. To have a mechanism through which people don\u2019t have to wait until FDA approval to receive this medication \u2014 potentially allowing a person who otherwise may be in the last few months of their life live more than a year \u2014 is a fantastic opportunity.\u201d<\/p>\n<p>Still, oncologists must ensure the enthusiasm surrounding this treatment is framed through the lens of realistic expectations.<\/p>\n<p>\u201cI had a conversation with a patient [recently] who asked, \u2018Is this a cure?\u2019 It is not,\u201d Coveler said. \u201cHowever, it is amazing to have a medication that we hope most patients will respond to and, even though there are side effects, it\u2019s likely they will be significantly less than the toxicity with chemotherapy. So, it still will be a paradigm shift in treatment, and the ultimate goal is to help our patients buy more time until we identify something that is even more effective and even better tolerated.\u201d<\/p>\n<h2>\u2018A new era\u2019<\/h2>\n<p>The role of <i>RAS<\/i> genes in cancer, first documented in the early 1980s, has been the subject of intense research since the 1990s.<\/p>\n<p>The commitment to overcome what has long been an undruggable driver mutation is paying off, Coveler said.<\/p>\n<p>\u201cThis drug is not something people accidentally found could work,\u201d Coveler said. \u201cThis is due to more than 30 years of solid dedication in the science community. I believe this is the beginning of an amazing time for targeted treatment.\u201d<\/p>\n<p>Complete data from RASolute 302 will be presented during the plenary session at ASCO Annual Meeting, scheduled for May 29-June 2 in Chicago. Anticipation already is building about how the capacity crowd in McCormick Place\u2019s Hall B1 will respond.<\/p>\n<p>In 2010, ASCO attendees gave a standing ovation following the presentation of data from a randomized phase 3 trial that showed first-line FOLFIRINOX extended survival by 3.5 months vs. gemcitabine for patients with metastatic pancreatic cancer.<\/p>\n<p>\u201cI can only imagine what it will be like after we hear these data, knowing we are seeing decades of research in this area come to fruition,\u201d Coveler said.<\/p>\n<p>Kamath has made sure he has no meetings scheduled \u201canywhere close\u201d to the start time of ASCO\u2019s plenary session. Like Coveler, he is optimistic that this is the first step in a broader transformation of pancreatic cancer treatment.<\/p>\n<p>Multiple trials are underway to further evaluate daraxonrasib for pancreatic cancer, including one evaluating it as first-line treatment of metastatic disease.<\/p>\n<p>Another agent in Revolution Medicines\u2019 pipeline \u2014 zoldonrasib (RMC-6291), which targets <i>KRAS<\/i> G12D mutations \u2014 is being advanced into pivotal phase 3 trials for metastatic PDAC and non-small cell lung cancer.<\/p>\n<p>Dozens of other RAS inhibitors are in various stages of clinical development.<\/p>\n<p>\u201cTo me, this is more like the dawn of a new era and less about celebrating an individual drug,\u201d Kamath said. \u201cIf you look at the way we treated pancreatic cancer in 2000, 2010, 2020 and now, you wouldn\u2019t see a meaningful difference. To finally be at the point where we are able to change that narrative is incredibly powerful.\u201d<\/p>\n<h2>For more information:<\/h2>\n<p>      <b>Andrew L. <\/b><b>Coveler<\/b><b>, MD, <\/b>can be reached at acoveler@uw.edu.<\/p>\n<p>      <b>Suneel Kamath, MD, <\/b>can be reached at kamaths@ccf.org.<\/p>\n<div class=\"article__content--footer\">\n<div class=\"publisher-logo\">\n    <span>Published by:<\/span><br \/>\n    <img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.healio.com\/~\/media\/h5\/feature\/news\/publogos\/hot.svg?la=en&amp;h=24&amp;w=141&amp;hash=2F86D471C8514C0E334E329AA799E8B4\" class=\"logo-img\" height=\"24\" alt=\"hemonc today logo\" width=\"141\"\/>\n  <\/div>\n<div class=\"sources-references-disclosures\">\n<h3>Sources\/Disclosures<\/h3>\n<h2> Source: <\/h2>\n<p class=\"citation\">Healio Interviews<\/p>\n<h2>References:<\/h2>\n<div class=\"disclosures\">\n<p>&#13;<br \/>\n        <strong> Disclosures: <\/strong>&#13;<br \/>\n        Coveler and Kamath report no relevant financial disclosures.&#13;\n      <\/p>\n<\/p><\/div>\n<\/div>\n<p><!-- Healio AI Widget --><\/p>\n<div class=\"healio-ai-component-inline\" data-no-ads=\"true\" data-module-track-category=\"Healio AI\" data-module-track-action=\"Click\" data-module-track-label=\"Access Healio Ai from component - News_AI Component - In-Content (all devices)\">\n<div class=\"healio-ai-content\">\n    <img decoding=\"async\" src=\"https:\/\/m3.healio.com\/~\/media\/images\/healio-ai\/healio-ai_logo.svg\" alt=\"Healio AI\" class=\"healio-ai-logo\"\/><\/p>\n<p><strong>Ask a clinical question<\/strong> and tap into <strong>Healio AI&#8217;s knowledge<\/strong> base.<\/p>\n<ul>&#13;<\/p>\n<li>PubMed, enrolling\/recruiting trials, guidelines<\/li>\n<p>&#13;<\/p>\n<li>Clinical Guidance, Healio CME, FDA news<\/li>\n<p>&#13;<\/p>\n<li>Healio&#8217;s exclusive daily news coverage of clinical data<\/li>\n<p>&#13;\n    <\/ul>\n<p>    <button class=\"healio-ai-button\" onclick=\"window.location.href=\" https:=\"\">Learn more<\/button>\n  <\/div>\n<\/div>\n<div class=\"email-alert-button-wrapper d-none\" data-component=\"EmailTopicAlert\" data-module=\"Subspecialty Email Topic Alerts Top\" data-manage-email-link=\"\/footer\/account-information\/my-account\/email-subscriptions-and-alerts#emailAlerts\">\n  <hidden data-setting-item=\"d265901d-6d37-49c7-a8f6-c7bf19a02509\"\/><br \/>\n  <hidden data-crm-source=\"Subspecialty Topic Alert\"\/><\/p>\n<div class=\"email-alert-button d-none\" data-topic-button=\"not-subscribed\">\n<p>&#13;<br \/>\n      <span data-module-track-action=\"Email Alerts TOP_Click_Healio News Article\" data-module-track-label=\"Email Alerts TOP_Healio News Article\">&#13;<br \/>\n        <i class=\"fas fa-plus-circle\"\/>&#13;<br \/>\n        Add topic to email alerts&#13;<br \/>\n      <\/span>&#13;\n    <\/p>\n<div class=\"email-alert-inner collapse u4d40b438b92448f0ae60ae3fa76a3205\">\n<div class=\"email-alert-dialogue\">\n<p>&#13;<br \/>\n          Receive an email when new articles are posted on <span data-content=\"topic-title\"\/>&#13;\n        <\/p>\n<div class=\"d-none\" data-sign-up-type=\"unknown\">\n          Please provide your email address to receive an email when new articles are posted on <span data-content=\"topic-title\"\/>.<\/p><\/div>\n<\/p><\/div>\n<p>      <button type=\"button\" class=\"btn btn-primary\" data-loading-text=\"Loading &lt;i class=\" fa=\"\" fa-spinner=\"\" fa-spin=\"\">&#8220;&#13;<br \/>\n              data-action=&#8221;subscribe&#8221;&gt;&#13;<br \/>\n        Subscribe&#13;<br \/>\n      <\/button>\n    <\/div>\n<\/p><\/div>\n<div class=\"d-none\" data-topic-modal=\"failed\">    <strong>We were unable to process your request. 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