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NEW — Additional Data on Daraxonrasib Released: “Significant Advances” for Pancreatic Cancer Treatment
Daraxonrasib is poised to become the new standard of care for previously treated metastatic pancreatic cancer after detailed results from a Phase III clinical trial were released at the American Society of Clinical Oncology (ASCO) annual meeting this weekend.
The presentation expanded on data previously provided by the oncology company Revolution Medicines in a press release in April. The once-daily pill essentially doubles overall survival in patients with previously treated metastatic pancreatic cancer compared with standard intravenous chemotherapy.
“The results presented at the ASCO meeting for daraxonrasib were jaw-dropping and represent the most significant advance we have ever seen in pancreatic cancer,” said PanCAN Chief Scientific and Medical Officer Anna Berkenblit, MD, MMSc. “For a disease that has long been marked by limited treatment options and often devastating outcomes, this is the beginning of a new era.”
This weekend’s meeting provided new insights into effectiveness, safety, side effects and more. Results were simultaneously published May 31 in the New England Journal of Medicine.
Here are some top take-aways:
Effectiveness: Clinical trial results showed that daraxonrasib doubled overall survival as compared to chemotherapy (13.2 months compared to 6.7 months). More than 91% of patients in the trial had a KRAS mutation. The number of patients enrolled in the trial who did not have a KRAS mutation, known as wild type, was so small that more studies are needed to determine the effectiveness of this drug in that patient population.
Progression-free survival, or how long a patient lives without the cancer getting worse, also improved with daraxonrasib as compared to chemotherapy (7.2 months versus 3.6 months).
Ongoing clinical trials continue to explore how to improve daraxonrasib’s effectiveness for more patients with this disease, including testing it in combination with chemotherapy or other treatments, as the first treatment patients receive, or in earlier stages of the disease such as following surgery.
What this means for patients: If daraxonrasib is approved by the U.S. Food and Drug Administration (FDA), it stands to potentially become the first targeted therapy for the vast majority of patients with previously treated metastatic pancreatic cancer. Up until now, the approved targeted therapies have been for very small subsets of patients with pancreatic cancer.
PanCAN continues to recommend biomarker testing for all patients with pancreatic cancer for a few reasons. Patients who do not have a KRAS mutation are more likely to have a different actionable alteration and may benefit from other treatments. Also, biomarker testing results can help identify subsequent therapies if resistance to a treatment develops and the cancer progresses. Lastly, biomarker testing may help open the door to ongoing clinical trials.
Side effects and quality of life: Revolution Medicines’ presentation provided additional details about side effects, including what study participants reported as severe. Roughly 86% of patients in the clinical trial reported rash, with about 14% of those cases considered severe, according to the New England Journal of Medicine publication. Stomatitis — commonly known as mouth sores — was the second-most severe side effect: It was reported by 54% of participants, with 12% of cases severe. Discontinuation of therapy due to severe side effects occurred in about 1% of patients receiving daraxonrasib, compared with roughly 11% on chemotherapy.
We also learned more about several important quality of life measures. According to the company, patients treated with daraxonrasib reported significantly delayed deterioration in cancer-related pain, overall global health status and quality of life, compared to those treated with chemotherapy.
What this means for patients: Clinical trial participants who received daraxonrasib saw a better quality of life and improved pain control as compared to patients treated with chemotherapy. Supportive care for management of side effects like rash and mouth sores will be key moving forward.
What’s next: Revolution Medicines plans to take their data to the FDA for approval. The treatment has been granted a special status: daraxonrasib was selected for the FDA Commissioner’s National Priority Voucher pilot program, which is intended to accelerate the review of therapies aligned with U.S. national health priorities.
In the meantime, daraxonrasib is currently available through an Expanded Access Program (EAP). The EAP provides daraxonrasib to eligible adult patients at participating institutions with previously treated metastatic pancreatic adenocarcinoma, who have no comparable or satisfactory alternative therapy and are unable to participate in an ongoing daraxonrasib clinical trial. Patients should talk to their doctor to learn if daraxonrasib is an appropriate treatment option and share Revolution Medicines’ EAP policy. It contains information on how a licensed treating physician can request access to the EAP on behalf of their patient.
How PanCAN Patient Services can help:
- Contact PanCAN Patient Services for one-to-one support. Our Case Managers are ready to talk through any questions related to treatment options. They can provide educational resources, conduct a personalized clinical trial search and more.
- Biomarker testing of a patient’s tumor tissue is the first step to determining eligibility for ongoing trials and to help find the best treatment options. Patients can learn whether they have a KRAS mutation or other actionable alterations through biomarker testing. Patient Services Case Managers can answer questions and provide support to enroll. Our Know Your Tumor program provides free biomarker testing to eligible patients.
- Daraxonrasib is not yet approved by the FDA. PanCAN recommends that patients diagnosed with pancreatic cancer not delay treatment and talk to their healthcare team about all treatment options, including standard of care chemotherapy, clinical trials and the daraxonrasib EAP.
05/08/2026 — Expanded Access Program for Daraxonrasib Now Available
Details about an Expanded Access Program (EAP) for daraxonrasib are now available.
The EAP is intended to provide daraxonrasib to eligible adult patients with previously treated metastatic pancreatic adenocarcinoma, who have no comparable or satisfactory alternative therapy and are unable to participate in an ongoing daraxonrasib clinical trial.
To request access to the EAP:
- Talk to your doctor to learn if daraxonrasib is an appropriate treatment option for you.
- Share with your doctor the Expanded Access Program section of the Revolution Medicines website, located here: https://www.revmed.com/expanded-access-policy/. It contains information on how a licensed treating physician can request access to the EAP on behalf of their patient.
- Visit clinicaltrials.gov for more information about the EAP, including full eligibility criteria.
05/01/2026 — FDA Issues Expanded Access Authorization for Daraxonrasib
Today, the U.S. Food and Drug Administration (FDA) announced that it has issued a “safe to proceed” letter to Revolution Medicines, allowing the company to initiate an expanded access treatment protocol (EAP) for daraxonrasib for patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC).
Expanded access is a potential pathway for patients with serious or life-threatening conditions to gain access to investigational medicines outside of a clinical trial when they are unable to participate in a clinical trial and all other appropriate treatment options have been exhausted.
In response to the FDA’s letter, Revolution Medicines said that this “represents a critical step in the process of opening an EAP” and that they are “moving as quickly as possible to ensure safe and equitable access to daraxonrasib for eligible patients in the United States,” according to a statement from the company.
- Read Revolution Medicines’ Expanded Access Policy, including how to submit a request through a licensed treating physician.
04/13/2026
A new therapy that targets RAS mutations present in more than 90% of patients with pancreatic adenocarcinoma — the most common type of pancreatic cancer — approximately doubles overall survival according to clinical trial results announced today.
Revolution Medicines shared Phase III clinical trial results for a pill called daraxonrasib in patients with previously treated metastatic pancreatic cancer. For decades, RAS was considered “undruggable,” meaning that there was no effective way to target RAS. These results greatly expand the potential benefit of targeted therapies for patients with pancreatic cancer.
“We are standing at the threshold of groundbreaking treatments for patients with pancreatic cancer,” said PanCAN Chief Scientific and Medical Officer Anna Berkenblit, M.D., MMSc. “Today’s announcement represents a real opportunity to bring new hope for people facing this disease: hope for more time with family, hope for better quality of life and hope that ongoing and future research may ultimately lead to a cure.”
Next, Revolution Medicines will need to take their data to the U.S. Food and Drug Administration (FDA). If the FDA grants approval for daraxonrasib, it will be made available as a treatment for patients with metastatic pancreatic adenocarcinoma who have been previously treated.
In this blog post, PanCAN addresses questions related to this news.
What was the news announced today? What are the key takeaways?
Revolution Medicines, a clinical oncology company, announced positive results from its Phase III clinical trial comparing their once-daily pill daraxonrasib with the current standard of care chemotherapy in patients with previously treated pancreatic adenocarcinoma that has spread beyond the pancreas (metastatic). It was a global, randomized trial, meaning that patients from more than 60 locations around the world were randomly assigned to one of these two treatment groups.
According to a press release from the company, daraxonrasib demonstrated a median overall survival of 13.2 months versus 6.7 months for chemotherapy. Overall survival measures the length of time from when treatment begins until death from any cause.
What are the side effects?
In their press release, Revolution Medicines states that “Daraxonrasib was generally well tolerated, with a manageable safety profile and with no new safety signals.” Prior studies with daraxonrasib have shown that rash is the most common side effect, with mouth sores, diarrhea, nausea and vomiting also common.
Let’s talk more about RAS mutations. What are they and why have they been a focus for researchers studying treatments for pancreatic cancer?
RAS mutations are changes in the RAS family of genes, which regulate cell growth and division. Mutations in RAS can cause cancer cells to grow uncontrollably, leading to cancer. RAS mutations, particularly in the KRAS gene, are found in over 90% of pancreatic cancer cases. Mutations in KRAS can “switch on” signals for constant cell growth, driving tumor formation and progression. These mutations are typically somatic mutations, meaning they occur in tumor cells during a person’s lifetime and are not passed down genetically. Identifying a KRAS mutation can guide treatment strategies and eligibility for clinical trials. It is one of the most studied genetic drivers in pancreatic cancer. KRAS inhibitors like daraxonrasib work by stopping the activity of RAS proteins, blocking signaling pathways that promote growth.
What’s the next step for this treatment?
Additional data from this trial is expected to be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in late May 2026. Revolution Medicines has announced their intent to take their data to the U.S. FDA for approval. The treatment has been granted a special status: daraxonrasib was selected for the FDA Commissioner’s National Priority Voucher pilot program, which is intended to accelerate the review of therapies aligned with U.S. national health priorities.
I am a patient with pancreatic cancer interested in this treatment. What should I do?
The RASolute 302 clinical trial has closed and is no longer enrolling patients. At this time, Revolution Medicines does not have a program for expanded access/compassionate use. Daraxonrasib is being studied in additional clinical trials in other patient populations. Trials of other investigational therapies targeting RAS in pancreatic cancer are ongoing.
Biomarker testing of a patient’s tumor tissue is the first step to determining eligibility for these trials and to help find the best treatment options. Patients can learn whether they have a KRAS mutation through biomarker testing. Biomarker testing will also tell patients the specific KRAS mutation present.
Patient Services Case Managers can answer questions about biomarker testing and provide resources to enroll. Many major cancer centers offer biomarker testing. Also, our Know Your Tumor program provides free biomarker testing for eligible patients. Contact PanCAN Patient Services to learn more.
Contact PanCAN Patient Services for information on active clinical trials and other treatment options and support. Our Case Managers can answer your questions and connect you with resources to learn about pancreatic cancer treatments and more.
