FDA Building 1 at the White Oak campus in Silver Spring, Maryland, which houses the commissioner’s offices.

U.S. Food and Drug Administration

Composite story

FDA approves daraxonrasib, a RAS-targeted pill that nearly doubled survival in metastatic pancreatic cancer

Rasonque, from Revolution Medicines, is the first broad RAS inhibitor cleared for previously treated metastatic pancreatic adenocarcinoma. A 500-patient trial showed median overall survival of 13.2 months versus 6.7 months on chemotherapy.

The FDA on Wednesday approved Rasonque (daraxonrasib), Revolution Medicines’ once-daily RAS-targeted pill, for adults with metastatic pancreatic adenocarcinoma after prior therapy or who cannot take multiagent chemotherapy. In a 500-patient trial, median overall survival was 13.2 months versus 6.7 months on chemotherapy, a 60% lower risk of death. The list price is $39,800 for a 30-day supply. More than 2,000 patients already received the drug through expanded access. Approval came about 6.5 months before the user-fee deadline.

Shared facts

The FDA just approved a breakthrough drug for pancreatic cancer that significantly extends patients’ lives.

The trial showed daraxonrasib doubles survival time.

Rasonque is the first approved medicine designed to broadly target RAS in pancreatic cancer.

Approval makes it available to people with metastatic pancreatic cancer who have already been through chemotherapy.

The FDA approved it about 6 1/2 months before the user-fee deadline.

The medication is daraxonrasib from Revolution Medicines, sold as Rasonque.

The once-daily pill is now available by prescription in the United States.

More than 90 percent of pancreatic cancers carry KRAS mutations once considered difficult to target.

It is a once-daily pill developed by California-based Revolution Medicines, known generically as daraxonrasib.

In the overall trial population, median survival was 13.2 months versus 6.7 months on chemotherapy.

It is designed to block active forms of RAS that drive tumor growth in most pancreatic adenocarcinomas.

Revolution set wholesale acquisition cost at $39,800 for a 30-day supply.

A phase 3 trial of 500 previously treated metastatic patients assigned them to daraxonrasib or chemotherapy.

Rasonque was associated with fewer severe side effects than chemotherapy.

Common side effects included rash, diarrhea, mouth sores, nausea, fatigue, vomiting and abdominal pain.

Kyle Diamantas said it is the FDA’s duty to deliver meaningful treatments as quickly as possible.

It had Breakthrough Therapy and Orphan Drug designations, Priority Review and a Commissioner’s National Priority Voucher review.

Before full approval, the FDA allowed expanded access for eligible previously treated metastatic patients.

Reuters reported more than 2,000 patients had enrolled in expanded access by approval.

Pancreatic cancer is often not detected until it has spread and remains among the deadliest cancers.

Revolution said it will offer patient support through its (ON) Path program.

ACS expects more than 67,000 U.S. diagnoses this year.

ACS estimates more than 52,000 U.S. deaths from the disease in 2026.

Aung said similar mutations are also found in other cancers.

Ben Sasse described on 60 Minutes how he has had less pain while taking the drug.

RAS mutations often leave the gene stuck “on,” telling cancer cells to keep growing, and daraxonrasib targets that.

Disputed facts

It has the lowest five-year survival of any major cancer, around 13 percent.

Shared opinions

The magazine said daraxonrasib could make a radical difference.

Shroff said Wednesday this is the start of the RAS revolution and a sea change for cancer.

Disputed opinions

None yet.

U.S. Food and Drug Administration

FDA Approves First in Class Targeted Therapy for Metastatic Pancreatic Cancer

FDA News Release

26 Aug 2026

Facts

Pancreatic adenocarcinoma arises from cells lining the ducts of the pancreas.

About 90% to 95% of the 67,000 new U.S. pancreatic cancers each year are adenocarcinoma, per NCI.

Though about 3.2% of cancer diagnoses, pancreatic adenocarcinoma causes a disproportionate share of cancer deaths.

Despite representing roughly 3.2% of all cancer diagnoses, pancreatic adenocarcinoma accounts for a disproportionately high share of cancer deaths, owing to its typically late detection, aggressive disease course, and historically limited treatment options.

fact

The FDA granted the approval to Revolution Medicines.

Opinion

Acting Commissioner Kyle Diamantas said today’s approval provides a critical new option for a historically hard-to-treat cancer.

“Today’s approval provides a critical new option for patients facing an extraordinarily difficult and historically hard-to-treat cancer. It is our fundamental duty to deliver more cures and meaningful treatments to patients as quickly as possible,” said Acting FDA Commissioner Kyle Diamantas, J.D. “I am immensely proud of the dedicated FDA scientists whose fast, thorough review and relentless commitment made this groundbreaking milestone a reality.”

attribution · Kyle Diamantas

The FDA said the action shows a commitment to moving with urgency and reducing unnecessary delays.

This action demonstrates the agency’s commitment to moving with urgency, reducing unnecessary delays and advancing innovative treatments that can make a meaningful difference in the lives of American patients and their families.

“Today’s approval provides a critical new option for patients facing an extraordinarily difficult and historically hard-to-treat cancer. It is our fundamental duty to deliver more cures and meaningful treatments to patients as quickly as possible,” said Acting FDA Commissioner Kyle Diamantas, J.D. “I am immensely proud of the dedicated FDA scientists whose fast, thorough review and relentless commitment made this groundbreaking milestone a reality.”

center · pluralist

Angelo de Claro said the drug showed unprecedented results in an area of high unmet need.

“This drug showed unprecedented results in an area of high unmet need,” said Angelo de Claro, M.D., director of the FDA’s Oncology Center of Excellence. “The approval was granted 6.5 months before the user fee deadline, demonstrating the FDA’s commitment to accelerating the approval of new cancer treatments for patients with serious and life-threatening conditions.”

attribution · Angelo de Claro

Reuters

Revolution's lifesaving pancreatic cancer drug wins speedy FDA approval

Padmanabhan Ananthan, Kamal Choudhury, Christy Santhosh and Julie Steenhuysen

26 Aug 2026

Facts

When Revolution announced trial results in April, demand surged.

Barbara Andes, 88, of Fullerton, California, said the pill let her resume regular activities with far less nausea and fatigue after a year of chemotherapy.

Barbara Andes, 88, of Fullerton, California, who began taking it in July after a year of chemotherapy, said the pill allowed her to resume regular activities and caused far less nausea and fatigue.

attribution · Barbara Andes

Early-access patients have already had a reprieve from the toll of chemotherapy.

It was reviewed under an FDA expedited process meant to shrink timelines to one to two months from the usual 10 to 12.

Investors have driven Revolution’s stock up 166% this year on hopes Rasonque will be a major treatment.

Approval was widely expected and shares were relatively flat at $211.70.

Longer term, RBC estimated $11.5 billion in annual global sales.

RBC said rapid approval and the expanded-access base could drive about $28 million in U.S. pancreatic cancer revenue in the third quarter.

RBC Capital Markets analysts said the rapid approval, along with more than 2,000 patients already enrolled in the Expanded Access Program, could help drive an estimated $28 million in U.S. pancreatic cancer revenue in the third quarter.

attribution · RBC Capital Markets analysts

Shroff said people lived longer and their quality of life improved, staying on the drug longer than on chemotherapy.

RBC said fourth-quarter sales could reach $148 million.

Opinion

Andes said commercial access will open the door for many more people who are suffering.

CEO Mark Goldsmith said the approval validates more than a decade of work on RAS-driven pancreatic cancer.

"This approval validates more than a decade of work aimed at pancreatic cancer, primarily RAS-driven disease, and one of the most difficult challenges in medicine, cancer biology, and drug discovery," Revolution CEO Mark Goldsmith said.

attribution · Mark Goldsmith

Peter Hosein described the result as a paradigm shift.

Peter Hosein, associate director for clinical research at the Pancreatic Cancer Research Institute at Sylvester Comprehensive Cancer Center, described it as a paradigm shift.

"Researchers have been trying to make a breakthrough in RAS inhibition for decades and, due to unrelenting persistence, this breakthrough is finally here," he said.

attribution · Peter Hosein

The Guardian

FDA gives expedited approval to new groundbreaking pancreatic cancer drug

The Guardian

26 Aug 2026

Facts

The approach has eluded drugmakers for decades.

The drug uses a molecular glue to bind multiple KRAS subtypes.

KRAS mutations are especially critical in fueling pancreatic cancer.

Unlike other cancers with many chemotherapy alternatives, pancreatic cancer has been harder to tackle.

The drugmaker is based in Redwood City, California.

Opinion

Doctors expressed optimism that approval may usher in more options, with dozens of experimental drugs in development.

NBC News

FDA approves ‘game-changing’ pancreatic cancer drug

Berkeley Lovelace Jr.

26 Aug 2026

Facts

Ben Sasse, who took the drug in a trial, described the rash as “nuclear” on a New York Times podcast.

The drug does have side effects, including a blistering rash, sores in the mouth and throat, and vomiting and diarrhea. (Former Sen. Ben Sasse of Nebraska, who got the drug in a clinical trial, described the rash as “nuclear” on a New York Times podcast in the spring.)

attribution · Ben Sasse

Der said pancreatic cancer is the third leading cause of U.S. cancer death and the deadliest of all cancers.

Scientists have long known that targeting the mutation could force the switch off.

There is no screening, and vague early symptoms mean most people are diagnosed at later stages.

Patients who lived longer in the trial received only Rasonque, not Rasonque plus chemotherapy.

Opinion

Shroff called it a game changer and unprecedented for doctors who treat pancreatic cancer.

Rachna Shroff said she started crying tears of joy when she saw the trial’s preliminary findings in April.

Dr. Rachna Shroff, chief of the division of hematology and oncology at the University of Arizona Cancer Center in Tucson, previously told NBC News that she “started crying tears of joy” when she saw the trial’s preliminary findings in April.

attribution · Rachna Shroff

Channing Der called the approval a monumental moment for treating pancreatic cancer.

Channing Der, a pharmacologist at the University of North Carolina at Chapel Hill, called Wednesday’s approval a “monumental moment for the treatment of pancreatic cancer.”

“This is just the beginning of more advances to come.”

attribution · Channing Der

Newsweek

FDA Approves Rasonque for Pancreatic Cancer: When It’s Available and Cost

Gabe Whisnant

26 Aug 2026

Facts

It does not require a companion diagnostic and can be used regardless of RAS mutation status.

Approval was based on the Phase 3 RASolute 302 trial of 500 previously treated metastatic patients.

That figure is a list price, not necessarily what patients will pay.

Revolution Medicines is California-based.

Revolution said some commercially insured patients may pay as little as $0 with co-pay assistance.

The drug reduced the risk of death by 60 percent and delayed disease progression.

The drug reduced the risk of death by 60 percent and also delayed disease progression.

When Wolpin advanced to a slide showing that the once-daily pill cut the risk of death by 60 percent in patients with previously treated metastatic pancreatic cancer, the packed auditorium erupted as attendees cheered, whistled and applauded.

fact

As an oral home therapy, it would generally be expected to fall under Medicare Part D rather than Part B.

Because Rasonque is an oral therapy taken at home, it would generally be expected to be covered through Medicare's Part D prescription drug benefit rather than Part B, which typically covers physician-administered treatments such as infusions.

fact

Out-of-pocket costs are expected to vary with insurance and assistance.

PanCAN said FDA approval generally leads Medicare and Medicaid to cover a drug, though insurers set cost-sharing.

The Pancreatic Cancer Action Network (PanCAN) says that, while the FDA does not determine insurance coverage, FDA approval generally leads Medicare and Medicaid programs to provide coverage, though insurers still determine reimbursement policies and patient cost-sharing.

attribution · Pancreatic Cancer Action Network

Lead investigator Brian Wolpin of Dana-Farber presented the drug at ASCO in Chicago on May 31.

The drug was unveiled by lead investigator Dr. Brian M. Wolpin, director of the Hale Family Center for Pancreatic Cancer Research at Dana-Farber Cancer Institute, during the plenary session of the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago on May 31.

fact

When Wolpin showed a 60 percent cut in death risk, the ASCO auditorium erupted in a standing ovation.

When Wolpin advanced to a slide showing that the once-daily pill cut the risk of death by 60 percent in patients with previously treated metastatic pancreatic cancer, the packed auditorium erupted as attendees cheered, whistled and applauded.

fact

Video clips of the ovation received millions of views on social media.

Opinion

Shubham Pant compared KRAS to a shiny ball that drugs slide off.

Pashtoon Kasi said it is not a cure but the best option patients have ever had.

Anna Berkenblit said PanCAN is watching the financial impact of new pancreatic cancer treatments.

Anna Berkenblit, chief scientific and medical officer at PanCAN, said the organization is closely watching the potential financial impact of new pancreatic cancer treatments.

"The potential financial burden of new therapies for pancreatic cancer patients, including what they may ultimately face in out-of-pocket costs, is an issue that PanCAN is concerned about," Berkenblit told Newsweek via email. "Cost should not become a barrier to patients who may benefit from a new treatment."

attribution · Anna Berkenblit

Specialists said the results are a significant advance even though the treatment is not a cure.

Kasi said the approval has opened doors for other companies and more trials in other tumor types.

Mark Lewis wrote that it feels like a historic moment as RAS targeting has arrived.

Wolpin quipped that the ovation time was not built into his talk.

Samuel Hume called the standing ovation for the full results one of the most amazing things he had seen.

Scientific American

U.S. approves breakthrough pancreatic cancer drug, heralding a new era for an intractable disease

Claire Cameron

26 Aug 2026

Facts

Scientific American reported it as a two-pills-a-day regimen.

In patients with those mutations, median overall survival was 13.2 months versus 6.6 months on chemotherapy.

Chemotherapy and other traditional treatments tend to fail, especially at later stages.

Scientific American said it was unclear how much the drug will cost.

Kyaw Lwin Aung said daraxonrasib is a targeted treatment that hits activated KRAS, not chemotherapy.

"Daraxonrasib is a targeted treatment, not chemotherapy. It works differently from chemotherapy by targeting activated KRAS protein in pancreatic cancer cells," explains Kyaw Lwin Aung, a medical oncologist at Baptist Health Herbert Wertheim Cancer Institute.

attribution · Kyaw Lwin Aung

Some patients who got the drug lived for years, which few people with late-stage pancreatic cancer do.

Aung was involved in the trial showing daraxonrasib doubles survival time.

Revolution Medicines did not immediately respond to a request for comment.

Opinion

Aung said doctors can now envisage a future with no chemotherapy needed for pancreatic cancer patients.

Aung said the approval opens KRAS-targeted treatment for other cancers, with more advances coming.