Results from a major study on daraxonrasib for pancreatic cancer that showed a nearly doubling of median survival rates earned a standing ovation from doctors at the 2026 American Society of Clinical Oncology meeting.
That kind of enthusiasm is rare in a room full of scientists. But so is this kind of progress in treatment for one of the deadliest forms of cancer.
"It's arguably the biggest, most important advance in the last 13 to 15 years in pancreatic cancer," says Jeremy B. Jacox, MD, PhD, a gastrointestinal medical oncologist at Yale School of Medicine and Smilow Comprehensive Cancer Hospital.
In August 2026, the FDA approved daraxonrasib, sold under the brand name Rasonque, for certain adults with metastatic pancreatic adenocarcinoma who:
- Have received at least one previous systemic therapy, or
- Aren't able to take multiagent systemic therapy
It isn't a cure, and it may not be the right treatment for everyone. But the study results and FDA approval give people with advanced pancreatic cancer a new choice that may offer more time and longer cancer control.
Daraxonrasib's (Rasonque's ) Journey to FDA Approval
Before full approval, the FDA granted daraxonrasib breakthrough therapy and orphan drug designations. The agency also picked it for the FDA commissioner's National Priority Voucher pilot program, which is meant to speed up review for certain drugs that may address major unmet public health needs.
What was the daraxonrasib expanded access program?
Some people were able to get daraxonrasib before full FDA approval through expanded access, also called compassionate use.
Expanded access lets certain people with serious or life-threatening illnesses get an investigational drug outside of a clinical trial. This option is generally reserved for people who don't qualify for a study or don't have access to one nearby.
What does full FDA approval mean?
The approved group goes beyond just those studied in RASolute 302. The phase 3 trial enrolled people whose metastatic cancer had worsened after previous treatment and who were also well enough to take part in a clinical trial.
"Full commercial approval means that a broader population of patients with metastatic pancreatic cancer can be considered for treatment with a once-daily regimen," Jacox says.
One important part of the approval is that some people who aren't a good fit for multidrug systemic treatment may now be able to take daraxonrasib even if they haven't already tried another systemic therapy.
But Jacox cautions against assuming that everyone will have the same results. People who are less healthy than those enrolled in the trial may not get as good of a response or handle treatment the same way.
What Is Daraxsonrasib (Rasonque)?
Daraxonrasib is a targeted therapy known as a RAS(ON) inhibitor. It's a pill you take once a day that's designed to block a major signaling protein called RAS. These proteins help send growth signals inside cells.
In many pancreatic cancers, a change (mutation) in the KRAS gene causes the RAS protein to get stuck in the "on" position. That tells cancer cells to keep growing, which makes tumors expand.
KRAS mutations are found in more than 90% of pancreatic ductal adenocarcinomas, the most common type of pancreatic cancer. Researchers have known this was one of the disease's most important targets for decades. But they couldn't find a good way to block it.
Daraxonrasib doesn't fix the RAS gene change. Instead, it offers a way to block the abnormal signal that triggers cancer growth, a goal that's been central to pancreatic research but very hard to reach.
"We're starting to drug the undruggable, and we're cracking open a box that's never been opened before," Jacox says. "And that's what is so exciting about this."
How Is Daraxonrasib (Rasonque) Different From Other Pancreatic Cancer Treatments?
Gladys Rodriguez, MD, an assistant professor and gastrointestinal medical oncologist at Northwestern Medicine, says most people with metastatic pancreatic cancer (cancer that's spread to other parts of the body) start treatment with IV chemotherapy.
Chemotherapy can help slow cancer growth. But it targets both fast-growing healthy cells and cancerous ones, causing several side effects, such as low blood counts, infection risk, fatigue, and numbness or tingling in the hands and feet.
Daraxonrasib is different in three main ways:
It's a pill. In the RASolute 302 trial, people took daraxonrasib by mouth once a day. Standard chemotherapy for advanced pancreatic cancer is usually given through a vein, often through a small device under the skin called a port.
It's more focused. Chemotherapy targets many cells that grow and divide quickly. Daraxonrasib goes after a common signal that's active in many pancreatic cancer cells.
It targets several RAS mutation types. Some targeted drugs work only if the cancer has a very specific mutation. Daraxonrasib is designed to block active RAS signaling across several common mutation types. That broader reach is part of what makes the daraxonrasib results so promising.
"I think it just proves that targeting this pathway can really change the outcomes in many patients with pancreatic cancer," Rodriguez says.
How does daraxonrasib work?
To understand why doctors consider daraxonrasib such a breakthrough, it helps to know why RAS has been such a difficult target.
Many targeted cancer drugs work a bit like a key fitting into a lock. Scientists find the right spot on a cancer protein, then design a drug that fits into that spot to shut it down.
But KRAS doesn't have an easy lock. The "keyhole" is almost impossible to get into because it's too shallow, Jacox says. Daraxonrasib took a different approach to fix the problem.
"The innovation was to realize that we don't need to find a key that gets into this lock," he says. "We just need to block off the doorknob."
Inside the cell, Jacox says, daraxonrasib works more like a "molecular glue." It sticks to RAS and another cell protein, called cyclophilin A, and holds them together in a way that blocks RAS from passing along growth signals.
Jacox also compares the process to disconnecting a computer from a network. You may not be able to fully shut the computer down, but you can stop it from sending messages.
Daraxonrasib (Rasonque) Clinical Trial Results
The main study behind the current buzz is called RASolute 302. This was a phase 3 clinical trial of 500 people with previously treated metastatic pancreatic cancer.
"Previously treated" means people had already received treatment for advanced cancer, usually chemotherapy, and the cancer had grown or stopped responding. This study didn't examine daraxonrasib as the first treatment after diagnosis.
Like many other cancer trials, RASolute 302 included people who were well enough to receive treatment. That means the results may not apply to every person with advanced pancreatic cancer.
People in the study were assigned to either:
- Daraxonrasib, taken as a pill
- Standard second-line chemotherapy
Researchers asked several key questions:
- How long did the person live?
- How long did it take for the cancer to grow?
- Did tumors get smaller?
- How did side effects compare?
- What happened to pain and quality of life?
Across these measures, the results looked better for those who took daraxonrasib.
Daraxonrasib and survival time
During the trial, people who took daraxonrasib had nearly double the median survival time (13.2 months) compared with the people who received chemotherapy ( 6.7 months). Median survival means half the people lived longer, and half lived for less time.
The study also found they had a 60% lower risk of death than those in the chemotherapy group.
Still, it's important to understand that daraxonrasib isn't a cure. The cancer often becomes resistant to treatment over time. But for someone with advanced pancreatic cancer, those extra months can be critical.
"I've cared for countless patients who would do anything to have more time with their loved ones," Jacox says. "If we can give them even a few more months with less pain and better quality of life, that matters."
Daraxonrasib and cancer growth
The study also looked at how long people lived before their tumors grew or the cancer spread. This is called progression-free survival. It was longer with daraxonrasib (7.2 months) than with chemotherapy (3.6 months).
That doesn't mean the cancer went away during that time. In many people, the tumor stayed the same size. But in pancreatic cancer, stable disease is often a sign that treatment is working.
Tumor shrinkage was also more common with daraxonrasib. They got smaller in 31.6% of people who took the pill, compared with about 11.2% of those who got chemotherapy.
Jacox says that kind of response isn't something doctors often see in second-line treatment for pancreatic cancer.
"These are patients who have been treated with cycles upon cycles of chemotherapy, with two or three drug combinations before, and they're still seeing some response," he says.
Daraxonrasib and genetic mutations
The trial focused mainly on people whose tumors had RAS G12 mutations. That includes common KRAS mutations found in pancreatic cancer. Daraxonrasib was also studied in people with other RAS changes, including G13 or Q61 mutations.
The drug appeared to benefit a smaller group of people whose tumors had no identified RAS mutation. That suggests daraxonrasib might help a broader group of patients, not just those with one specific RAS or KRAS mutation. But more research is needed to confirm these results.
It's important to know which mutation your tumor has. Biomarker testing is often a standard part of pancreatic cancer treatment, especially for advanced disease.
Tests identify KRAS, RAS, or other gene changes that may help guide treatment or clinical trial options. This is different from inherited genetic testing, which looks for gene changes you were born with and may share with family members.
You can ask your oncologist:
- Has my tumor had biomarker testing?
- Do we know my KRAS or RAS mutation status?
- Could my results affect my treatment choices?
- Could my results affect whether I can get daraxonrasib or join a clinical trial?
Daraxonrasib side effects and quality of life
Daraxonrasib was generally easier for people to stay on than chemotherapy in the RASolute 302 trial. In the trial, 1.2% of people in the daraxonrasib group stopped treatment due to side effects, compared to 11.2% of people in the chemotherapy group.
People who took daraxonrasib also had more time before their pain got worse, and their quality of life stayed stable for longer. But that doesn't mean daraxonrasib doesn't cause any unwanted symptoms. "It's better tolerated, not side-effect-free," Rodriguez says.
The most common side effects of daraxonrasib are:
- Rash or other skin reactions
- Nausea
- Vomiting
- Fatigue
- Diarrhea
- Stomatitis, or mouth inflammation/sores
- Belly pain
- Edema, or swelling
- Decreased appetite
- Bleeding
Jacox says a rash was one of the most notable side effects. In some people, it involved the face. In others, it affected larger areas of the body. Rashes, diarrhea, mouth ulcers, and similar symptoms can become severe. That may happen because RAS-targeting drugs can also affect cells that line the skin and gut.
The FDA prescribing information includes warnings about potentially serious problems, including severe skin or soft-tissue reactions, mouth problems, diarrhea, a hole in the gut lining, and lung inflammation.
Tell your cancer team about any side effects early, even if they seem small at first. Your oncologist or palliative care team may be able to adjust the dose or use treatments such as skin medicines, anti-nausea drugs, or mouth care to help you feel better and stay on treatment safely.
Who Can Benefit From Daraxonrasib (Rasonque)?
Daraxonrasib is FDA-approved for adults with metastatic pancreatic adenocarcinoma who've gone through at least one previous systemic therapy or who aren't candidates for multiagent systemic therapy.
You don't need to have a particular RAS or KRAS mutation to qualify under the FDA-approved guidelines.
The approval is specifically for pancreatic adenocarcinoma. It doesn't include pancreatic neuroendocrine tumors, which are different cancers and are treated differently.
Daraxonrasib isn't meant to prevent pancreatic cancer in the general public. Researchers may one day study RAS inhibitors in people at very high risk or in earlier disease, but that's not how this drug is being used now.
Whether daraxonrasib is right for you depends on your health, previous treatments, other medical conditions, and treatment goals. Talk with the doctor who treats your pancreatic cancer about all your options.
What's Next for Daraxonrasib?
The RASolute 302 trial tested daraxonrasib after earlier treatment had stopped working. It didn't test whether the drug should replace standard multiagent therapy as the first treatment for people who are healthy enough for it.
That said, the FDA approval does include adults with metastatic pancreatic adenocarcinoma who aren't candidates for multiagent systemic therapy.
Researchers are also looking at whether daraxonrasib might be used:
- As the first treatment instead of chemotherapy in some people
- In combination with chemotherapy or other drugs that target specific KRAS mutations
- After surgery for earlier-stage pancreatic cancer
- In other cancers driven by RAS or KRAS mutations
Jacox says the bigger question is whether daraxonrasib could become a new "backbone" or "cornerstone" of pancreatic cancer treatment, something doctors can build on with other therapies.
The approved uses for daraxonrasib may eventually go beyond pancreatic cancer. KRAS and RAS inhibitors are also being studied in other solid tumors, including colorectal and non-small-cell lung cancers.
Takeaways
Daraxonrasib (Rasonque) is an FDA-approved, once-daily targeted therapy for certain adults with metastatic pancreatic adenocarcinoma.
In the main study, people with previously treated metastatic pancreatic cancer lived longer on daraxonrasib than on standard second-line chemotherapy. The drug also slowed cancer growth and shrank tumors in some people.
The FDA approval includes adults who have received at least one previous systemic treatment as well as people who aren't candidates for multiagent systemic therapy. You don't need to have a particular RAS or KRAS mutation to qualify under the FDA-approved guidelines.
Daraxonrasib isn't a cure. It can cause side effects, including rashes or other skin reactions, nausea, vomiting, diarrhea, fatigue, and mouth sores.
A good question to ask your cancer care team is, "Could daraxonrasib (Rasonque) or a clinical trial be an option for me?"
Daraxonrasib FAQs
Is daraxonrasib chemo?
No. Chemotherapy attacks many fast-growing cells throughout the body. Daraxonrasib is a targeted therapy that blocks RAS signaling, a pathway often driven by KRAS mutations. This is a more focused approach, which usually means fewer side effects than chemo.
What cancer drug has 100% success?
No cancer drug works for everyone all the time. Some work very well for certain people with certain tumor markers. But every cancer is different, and even treatments that control cancer growth at first can stop working over time.
Has anyone ever beaten pancreatic cancer?
Yes. Some people diagnosed with pancreatic cancer live a long time, especially if it's found early and can be treated with surgery, chemotherapy, and close follow-up. But pancreatic cancer is often found after it's spread, which makes it a lot harder to treat.
How long can you live with stage IV pancreatic cancer?
Many people with advanced pancreatic cancer live months to about a year. You may live longer, especially if treatment works well.
