A New Pancreatic Cancer Pill Nearly Doubled Median Survival—Now the FDA Has Approved It

A new pill for advanced pancreatic cancer nearly doubled median overall survival in a large clinical trial, and the U.S. Food and Drug Administration has now approved it for certain adults whose disease has spread.

The FDA approved daraxonrasib, sold under the brand name Rasonque, on August 26, 2026. The once-daily tablet is the first approved medicine in a new class designed to inhibit the RAS family of proteins—molecular switches that drive the growth of many pancreatic tumors.

The approval is a meaningful advance for a cancer that remains exceptionally difficult to treat. It is not a cure, and the medicine is not intended for every newly diagnosed patient. But for eligible people with metastatic pancreatic adenocarcinoma, the pivotal study found a striking survival advantage over standard chemotherapy.

What the clinical trial found

In the randomized RASolute 302 trial, 500 adults received either daraxonrasib or a chemotherapy selected by their physician. According to the FDA’s detailed approval notice, median overall survival was 13.2 months with daraxonrasib, compared with 6.7 months in the chemotherapy group.

Median progression-free survival—the length of time patients lived before the disease worsened—was 7.2 months with the new drug and 3.6 months with chemotherapy. The objective response rate was 30% versus 11%, meaning tumors shrank by a predefined amount in nearly three times as many patients.

Those figures describe medians across the trial population, not a promise for any individual patient. Outcomes can vary widely depending on a person’s health, prior treatment and the biology of the tumor.

Who is eligible for Rasonque?

The FDA approved the 300-milligram oral dose for adults with metastatic pancreatic adenocarcinoma who have already received at least one systemic treatment, or who are not candidates for a multi-drug systemic regimen. Treatment continues once daily until the cancer progresses or side effects become unacceptable.

Pancreatic adenocarcinoma accounts for roughly 90% to 95% of the approximately 67,000 pancreatic cancer cases diagnosed in the United States each year, the FDA said in announcing the decision. The Associated Press reported that about 52,000 Americans die from the disease annually and that the five-year survival rate is about 13%.

A first-in-class attack on a notorious cancer driver

RAS mutations have long been recognized as major cancer drivers, but the proteins were once considered exceptionally difficult to target with drugs. Daraxonrasib, developed by Revolution Medicines, inhibits multiple forms of active RAS rather than focusing on only one mutation.

The agency reviewed the medicine through expedited programs and granted it breakthrough-therapy and orphan-drug designations. Reuters reported that the decision arrived about six and a half months earlier than the FDA’s original review deadline.

Side effects and a steep price

The most common side effects included rash, diarrhea, mouth inflammation, nausea, fatigue, vomiting, abdominal pain, swelling and reduced appetite. The prescribing information also carries warnings for serious skin and soft-tissue reactions, gastrointestinal perforation, interstitial lung disease or pneumonitis, bleeding and harm to a fetus.

Reuters and AP reported a list price of $39,800 for a 30-day supply. Revolution Medicines says assistance programs will be available, but actual out-of-pocket costs will depend on insurance coverage and eligibility.

Why this approval matters

Pancreatic cancer is often diagnosed only after it has spread, when surgery is no longer an option and treatment choices are limited. An oral targeted therapy that delivered both longer survival and a higher tumor-response rate represents a significant new option for eligible patients.

The next questions will be how the drug performs in wider clinical use, how clinicians manage its risks and how many patients can obtain it. For now, the approval gives oncologists a new tool against one of medicine’s most stubborn cancers—and gives some patients more time than current chemotherapy provided in the trial.