In a monumental leap for cancer treatment, health officials have sanctioned a novel drug that significantly boosts survival chances for pancreatic cancer patients.
On Wednesday, the FDA greenlit the use of daraxonrasib, a groundbreaking oral medication specifically designed to tackle the KRAS genetic mutation. This mutation is a known culprit behind nearly 90% of pancreatic cancer cases, making the drug a focal point for medical innovation.
Administered as two pills daily, daraxonrasib is now available for individuals battling metastatic pancreatic cancer—cases where the disease has spread to other parts of the body and previous chemotherapy treatments have been attempted.
In an influential clinical trial disclosed earlier this year, patients taking daraxonrasib enjoyed a median survival of 13.2 months. This period nearly doubles the typical survival time of patients undergoing chemotherapy, with some participants surviving several years post-treatment initiation.
Although not a definitive cure, the development of this drug represents an important beacon of hope for those afflicted by one of the United States’ most lethal cancers, which historically claims the vast majority of lives within five years.
‘We’ve never seen a benefit like this,’ Dr Anna Berkenblit, the chief scientific and medical officer at the Pancreatic Cancer Action Network, said.
Drug manufacturer Revolution Medicines said the approved daraxonrasib will be sold under the brand name Rasonque. The company has not yet announced how much the medication will cost.
However, since May, more than 2,000 patients have received free, early access to daraxonrasib through the FDA’s expanded access program, including former Nebraska Senator Ben Sasse, who was diagnosed with stage four pancreatic cancer in December.
The FDA has approved a daily pill that doubles survival odds in pancreatic cancer patients
Revolution Medicines said people receiving the drug through expanded access will transition to getting it covered through their insurance.
Pancreatic cancer strikes 67,000 Americans every year and kills 52,000, American Cancer Society data shows.
For decades, it was regarded as a disease of old age, most commonly affecting people over 65, particularly those with long-standing risk factors such as smoking, obesity or type 2 diabetes.
But over the past 20 years, doctors have warned an increasing number of patients in their 20s, 30s and 40s are being diagnosed, often without classic risk factors.
Population-level data appears to support those observations. According to the American Cancer Society, the lifetime risk of developing pancreatic cancer is one in 56 for men and one in 60 for women.
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While the disease remains rare in younger adults, incidence rates are rising steadily.
Between 2000 and 2021, pancreatic cancer diagnoses increased by 4.3 percent per year among Americans ages 15 to 34, and by 1.5 percent annually among those ages 35 to 54, according to a 2025 analysis.
In its early stages, symptoms are vague and easily dismissed: a dull back ache, intermittent indigestion, unexplained fatigue, subtle yellowing of the eyes or skin that comes and goes.
Ryan Dwars of Iowa with his family. He was diagnosed with stage four pancreatic cancer at 36
Doctors often describe it as a cancer that ‘whispers’ rather than shouts – and by the time it finally makes itself heard, it is frequently a death sentence. Its stealth is what makes pancreatic cancer uniquely dangerous.
Around 80 percent of cases are diagnosed only after the disease has spread beyond the pancreas, at which point surgery – currently the only potential cure – is no longer an option.
Overall, just 12 percent of patients survive for five years after diagnosis, and the majority do not live more than a year.
In May, researchers shared the results of a clinical trial involving 500 patients, with an average age of 66, from North America, Europe and Asia with metastatic pancreatic cancer who had previously received other treatments.
The above chart shows the survival rate of pancreatic cancer by stage
Just under half received daraxonrasib while the remaining patients were given standard chemotherapy.
The median survival was 13.2 months in the daraxonrasib group compared to 6.7 months for those who had chemotherapy. Daraxonrasib also caused fewer side effects than chemotherapy, with patients mainly reporting rash, diarrhea, fatigue and nausea.
About 90 percent of pancreatic cancers are driven by a mutated cellular protein called KRAS. Daraxonrasib is thought to ‘glue’ molecules together to shut down KRAS, slowing the spread of cancer cells.
Clinical trial lead Dr Brian Wolpin of Dana-Farber Cancer Institute in Boston said when the findings were unveiled at the American Society of Clinical Oncology’s annual meeting: ‘It is exciting that we may soon be able to help patients with metastatic [advanced] pancreatic cancer in ways we haven’t been able to before, improving both survival and quality of life.
‘I have not seen anything like that before in trials we have run in pancreatic cancer. I just kept repeating, “Wow,”‘