Revolution Medicines begins early access shipping of experimental pancreatic cancer drug
Revolution Medicines has begun the first shipment of its experimental pancreatic cancer drug daraxonrasib through an early-access programme, the company's CEO Mark Goldsmith told STAT News. In an interview, Goldsmith said the company plans to file with the US Food and Drug Administration (FDA) for approval 'soon', describing the clinical data as 'outstanding'. The announcement came on the second day of the American Society of Clinical Oncology (ASCO) 2026 meeting in Chicago.
Daraxonrasib is a next-generation small-molecule inhibitor targeting cancer cells carrying KRAS mutations. KRAS mutations are present in roughly 90 percent of pancreatic cancers and have historically been described as 'undruggable' oncogenes. While KRAS-targeting drugs have been developed in recent years, the specific mutation type for which they were effective, KRAS G12C, accounts for only around 3 percent of pancreatic cancer cases. Revolution Medicines's daraxonrasib has a target profile covering a broader family of KRAS mutations.
Per phase 1-2 data reported by STAT News, the trial of 84 advanced pancreatic cancer patients showed a median progression-free survival of 6.4 months. That figure is meaningfully longer than the roughly 2.5 months typically achieved with standard chemotherapy regimens in pancreatic cancer patients. Approximately 19 percent of patients showed objective tumour shrinkage; historically, this rate has been below 6 percent for second-line pancreatic cancer treatment.
Dr Pamela Munster, an oncologist at Stanford University School of Medicine who participated in the study, told STAT that 'this is genuinely a milestone in the past 20 years of pancreatic cancer treatment'. Munster added, 'for the past two years the prevailing view has been that KRAS-targeted drugs do not work in pancreatic cancer; daraxonrasib has now provided enough evidence to question that assumption'.
On safety, approximately 32 percent of patients experienced grade 3 or grade 4 adverse events, with the most common being fluid retention and oedema. Goldsmith said this level was 'lighter than the side-effect burden of conventional pancreatic cancer treatment regimens'. Still, Munster of Stanford noted that careful patient selection will be important in the drug's clinical use.
Under the early-access programme, the drug will reach patients who do not meet clinical trial criteria, through approximately 25 major cancer centres across the United States. According to STAT, the company plans to make the drug available to around 400 patients initially. Early access generally creates a previous option for patients with life-threatening conditions who have not responded to standard treatments.
On the financial side, Revolution Medicines's shares rose 22 percent at Wednesday's close following Goldsmith's announcement. The company's market value rose to approximately 5.4 billion dollars. The previous year's collaboration agreement with Pfizer gave Revolution Medicines access to a payment stream of up to 5.5 billion dollars with a 1.4-billion-dollar upfront payment. Pfizer holds rights to daraxonrasib sales outside the United States.
The FDA's independent oncology advisory committee is expected to convene in the coming months to review the daraxonrasib application. The most likely path to approval is via accelerated review status, with a market launch by the end of 2026 or early 2027. Goldsmith said, 'if we get approval, this is a treatment patients have been waiting for years to access'.
Pancreatic cancer is recognised as one of the world's most aggressive cancer types, with approximately 64,000 new cases and 51,000 deaths annually in the United States. Most patients are diagnosed when the disease has already advanced, and median five-year survival across all stages is around 12 percent. For that reason, any new effective treatment option for pancreatic cancer is considered clinically significant.
This article is not medical advice. Readers with a pancreatic cancer diagnosis or seeking treatment options should consult their oncology team, clinical research centres and the insurers that apply to early-access programmes. The FDA review process over the coming months could determine the long-term direction of pancreatic cancer treatment. STAT News's coverage noted that clinical researchers are also evaluating the potential of KRAS-targeted approaches beyond pancreatic cancer.