The U.S. Food and Drug Administration (FDA) has approved the first drug shown to substantially extend the lives of people with advanced pancreatic cancer, nearly doubling survival time in a key clinical trial.
The pill, Rasonque (daraxonrasib), was cleared Wednesday for adults whose pancreatic cancer has spread and who have already had at least one other drug treatment, or who cannot take combination chemotherapy.
In a trial of 500 adults, people who took Rasonque lived a median of 13.2 months (half lived longer and half for a shorter time), compared with 6.7 months for those on standard chemotherapy, the FDA said.
The once-daily tablet blocks RAS, a cell protein that fuels tumor growth in most pancreatic cancers. It is the first drug of its kind, reports The New York Times.
About 67,000 people in the United States are diagnosed with pancreatic cancer each year. Most of those cases are pancreatic ductal adenocarcinoma, which starts in the cells lining the ducts of the pancreas, according to the National Cancer Institute (NCI).
The disease is often caught late and has had few effective treatments, so it accounts for an outsized share of cancer deaths.
“This drug showed unprecedented results in an area of high unmet need,” said Dr. Angelo de Claro, director of the FDA’s Oncology Center of Excellence.
Acting FDA Commissioner Kyle Diamantas said the approval gives patients a critical new option for a historically hard-to-treat cancer and credited agency scientists with the speed of the review.
Dr. Brian Wolpin of the Dana-Farber Cancer Institute in Boston, who led the key study, told The Times he was stunned by the results.
“I have not seen anything like that before in trials we have run in pancreatic cancer,” he said.
The drug is not a cure, and it can cause harsh side effects. The most common are rash, diarrhea, mouth sores, nausea, fatigue, vomiting, belly pain, swelling, loss of appetite and bleeding.
Maker Revolution Medicines Inc. set a list price of $39,800 a month — about $478,000 for a year of treatment — though most of that is expected to be covered by insurance, with out-of-pocket costs varying, according to The Times.
More than 2,000 patients have already received the drug free through an early access program that began in May. The company said they will move to insurance coverage.
Former U.S. Sen. Ben Sasse of Nebraska, who said in December that he had metastatic pancreatic cancer, has credited the drug with extending his life after receiving it in a clinical trial, according to The Times.
RELATED: Blacks Are Dying of Pancreatic Cancer, But We’re Missing From Clinical Trials
Daraxonrasib (sold under the brand name Rasonque) is an targeted therapy taken as a pill. It works differently from traditional chemotherapy by targeting changes in cancer cells involving the RAS pathway. Researchers have been studying whether blocking these cancer-driving signals could slow tumor growth.
Black Americans face a higher incidence of pancreatic cancer and often have poorer outcomes from the disease. Several risk factors contribute these disparities, including underlying health conditions, environmental exposures, and lifestyle and social determinants of health (e.g., limited access to affordable, fresh, and nutritious foods, structural barriers to physical activity, etc.). Additionally, delayed diagnoses and gaps in treatment can also influence pancreatic cancer outcomes for Black patients.
Pancreatic cancer can also be difficult to detect early because symptoms may be vague or mistaken for other health problems.
The FDA’s approval of daraxonrasib is promising, but the targeted therapy can only make a difference if patients know about it and have access to the specialists, testing, and cancer care needed to determine whether it may be an option.
RELATED: Why Are Cases of Pancreatic Cancer Rising in Young Women?
Daraxonrasib’s approval represents a critical step forward for people with advanced pancreatic cancer, a disease that has historically had few effective treatment options. For Black patients, the next challenges is ensuring that advances like these reach the communities most affected by the disease — and that patients have the information and access necessary to discuss every available option with their healthcare provider.
More information
Visit the U.S. National Cancer Institute for more information about pancreatic cancer.
SOURCES: The New York Times, Aug. 26, 2026; U.S. Food and Drug Administration, Aug. 26, 2026
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