Breakthrough pancreatic cancer drug that DOUBLES survival gets FDA approval
Health officials have approved a breakthrough pancreatic cancer drug that doubles survival odds.
The FDA announced Wednesday it has approved daraxonrasib, a first-of-its-kind pill that targets the genetic mutation KRAS, which drives nearly 90 percent of pancreatic cancer cases.
Taken as two pills a day, the drug is approved for pancreatic cancer patients with metastatic disease, meaning it has spread to other organs, who have already tried chemotherapy.
In a key clinical trial unveiled earlier this year, participants who took daraxonrasib lived for an average of 13 months, nearly double the amount of time as those who received chemotherapy. Several patients even lived for years after starting the treatment.
While the drug is not a cure for pancreatic cancer, it does offer a glimmer of hope for one of America’s deadliest cancers, which kills nearly all patients 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.
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
Holly Shawyer of North Carolina was diagnosed with pancreatic cancer in her 30s despite being a marathon runner. Her main symptom was a stomach ache. ‘I was in great health before this,’ she said
Just under half received daraxonrasib while the remaining patients were given standard chemotherapy.
The average survival was 13 months in the daraxonrasib group compared to 6.6 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,”‘
