• Posted August 27, 2026

FDA Approves First Pill To Extend Survival In Advanced Pancreatic Cancer

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 adenocarcinoma, which starts in the cells lining the ducts of the pancreas, according to the National Cancer Institute. 

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.

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