The US Food and Drug Administration has approved daraxonrasib, a daily pill for patients with advanced pancreatic cancer that doubled median survival in clinical trials.
The federal health regulator announced Wednesday that it approved the first-of-its-kind oral drug, which will be manufactured by Revolution Medicines and sold under the brand name Rasonque. Taken as two pills a day, the treatment is approved specifically for patients with metastatic pancreatic cancer whose disease has spread to distant organs and who have previously received chemotherapy.
Daraxonrasib targets a mutated cellular protein known as KRAS, a key genetic driver that fuels nearly 90 percent of all pancreatic cancer cases. The gene normally regulates cellular growth, but when mutated, it sends continuous signals causing cells to divide uncontrollably. Daraxonrasib works by effectively gluing target molecules together to deactivate the mutated protein, slowing the multiplication and spread of malignant cells.
Although the medication is not a cure, oncologists say it offers a rare advancement for one of the deadliest malignancies in the United States, which kills nearly all diagnosed patients within five years.
"We've never seen a benefit like this," said Dr Anna Berkenblit, chief scientific and medical officer at the Pancreatic Cancer Action Network, a national non-profit advocacy organization dedicated to funding pancreatic cancer research and supporting patients.
Revolution Medicines has not yet announced the commercial retail price for Rasonque. However, more than 2,000 patients have received free, early access to daraxonrasib since May through the FDA's expanded access program, which allows patients with life-threatening conditions to receive experimental drugs prior to formal approval.
Among those receiving early access is former Nebraska Senator Ben Sasse, who was diagnosed with stage four pancreatic cancer in December. Revolution Medicines stated that patients currently receiving the drug through expanded access will transition to standard insurance coverage now that formal approval has been granted.
Clinical trial demonstrates doubled survival times
The FDA approval was based on findings from a major clinical trial unveiled earlier this year at the annual meeting of the American Society of Clinical Oncology. Lead trial investigator Dr Brian Wolpin, of the Dana-Farber Cancer Institute in Boston, presented results from a study involving 500 patients with metastatic pancreatic cancer across North America, Europe, and Asia.
Participants in the study had an average age of 66 and had all previously undergone other cancer treatments without success. Just under half of the trial cohort received daraxonrasib, while the remaining control group received standard chemotherapy treatments.
Patients treated with daraxonrasib achieved a median survival of 13.2 months, compared to 6.7 months for those receiving standard chemotherapy regimens. Researchers noted that several patients in the daraxonrasib group survived for years after beginning the pill regimen.
In addition to doubling median survival times, daraxonrasib caused fewer adverse side effects than conventional chemotherapy, which typically inflicts severe systemic toxicity. Patients taking daraxonrasib primarily reported mild to moderate side effects, including rash, diarrhea, fatigue, and nausea.
"It is exciting that we may soon be able to help patients with metastatic pancreatic cancer in ways we haven’t been able to before, improving both survival and quality of life," Dr Wolpin said during the presentation of the trial data. "I have not seen anything like that before in trials we have run in pancreatic cancer. I just kept repeating, 'Wow.'"
Rising incidence and diagnostic challenges
Pancreatic cancer remains a formidable public health challenge. Located behind the stomach, the pancreas produces digestive enzymes and essential hormones like insulin, but tumors in the organ are exceptionally difficult to detect in their early stages.
Data from the American Cancer Society indicates that approximately 67,000 Americans are diagnosed with pancreatic cancer each year, while roughly 52,000 die from the disease annually. The overall five-year survival rate stands at just 12 percent, with the majority of patients dying within a year of diagnosis.
Around 80 percent of cases are diagnosed only after the cancer has metastasized beyond the pancreas. At that late stage, surgical removal of the tumor, currently the only potential cure, is no longer a treatment option.
Early symptoms are notoriously vague and easily misdiagnosed, including a dull back ache, intermittent indigestion, unexplained fatigue, or subtle yellowing of the skin and eyes that comes and goes. Doctors frequently describe pancreatic cancer as a disease that whispers rather than shouts, meaning most patients remain asymptomatic until the disease is far advanced.
Pancreatic cancer was long regarded as a disease predominantly affecting older adults over age 65, particularly those with established risk factors such as smoking, obesity, or type 2 diabetes. However, over the past 20 years, physicians have warned of an increasing number of diagnoses among younger adults in their 20s, 30s, and 40s who lack traditional risk factors.
Population statistics reflect this trend. American Cancer Society data shows that the lifetime risk of developing pancreatic cancer is 1 in 56 for men and 1 in 60 for women. A 2025 demographic analysis found that between 2000 and 2021, pancreatic cancer diagnoses rose by 4.3 percent annually among Americans aged 15 to 34, and by 1.5 percent per year among those aged 35 to 54.
Among those diagnosed at a young age with advanced disease is Ryan Dwars of Iowa, who was diagnosed with stage four pancreatic cancer at age 36.
