Approved treatment — U.S. FDA (2026-08-26), previously treated metastatic pancreatic cancer Europe — CHMP positive opinion (2026-10-15) Japan — PMDA observed the review; adjuvant phase 3 trial registered
A new drug for pancreatic cancer: on August 26, 2026, the U.S. FDA approved daraxonrasib (Rasonque), a once-daily oral RAS inhibitor, for adults with metastatic pancreatic cancer that has progressed after at least one prior treatment. In the phase 3 RASolute 302 trial, median overall survival was 13.2 months, about twice the 6.7 months seen with standard chemotherapy.
What was approved: an oral pill that targets RAS directly
Pancreatic cancer has often already spread by the time it is diagnosed, and few drugs have been available after first-line chemotherapy, so new options have long been awaited. Most pancreatic cancers carry a KRAS gene mutation. RAS is a switch protein that tells cells to keep growing; when it is mutated, the switch stays locked in the "on" position and cancer cells keep multiplying.
RAS was long considered too difficult to target with drugs. Medicines that block one specific mutation (G12C) are now used in lung and colorectal cancer, but they do not work on the G12D and G12V mutations that are common in pancreatic cancer. Daraxonrasib is a RAS(ON) multi-selective inhibitor designed to act on several types of RAS in their active state, so it can be used across mutation types.
The dose is 300 mg taken by mouth once a day until the disease progresses or side effects become too difficult. The FDA granted breakthrough therapy and orphan drug designations, used Real-Time Oncology Review and the Commissioner's National Priority Voucher program, and approved the drug about 6.5 months ahead of its goal date.
Who is eligible: metastatic pancreatic cancer after first-line treatment
Under the FDA label, the drug is for adults with metastatic pancreatic adenocarcinoma who meet one of the following:
- have received at least one prior systemic therapy, or
- are not candidates for multiagent chemotherapy such as FOLFIRINOX
The approved indication does not require a specific RAS test result. In the trial, benefit was seen in patients with RAS G12 mutations and in the overall population. Genetic test results are still useful when considering other targeted drugs or clinical trials, so keep any tissue or blood test reports at hand.
RASolute 302 results: median survival of 13.2 months
The approval is based on the international randomized phase 3 trial RASolute 302 (NCT06625320). It enrolled 500 patients whose metastatic pancreatic cancer had progressed after first-line therapy: 248 received daraxonrasib and 252 received the physician's choice of standard chemotherapy. Results were presented at the 2026 ASCO Annual Meeting, and further subgroup analyses were shared at ESMO 2026 in October.
| Measure | Daraxonrasib | Standard chemotherapy |
|---|---|---|
| Median overall survival | 13.2 months | 6.7 months |
| Hazard ratio for death | 0.40 (95% CI 0.30–0.53) — 60% lower risk of death | |
| Median progression-free survival | 7.2 months | 3.6 months |
| Objective response rate (FDA) | 30% | 11% |
| Time until pain worsened | 9.2 months | 3.8 months |
| Grade 3 or higher treatment-related events | 43.6% | 57.5% |
| Stopped treatment due to side effects | 1.2% | 11.2% |
Sources: FDA approval notice (2026-08-26), OncLive summary of the ASCO 2026 presentation, Revolution Medicines ESMO 2026 release. Response rate is the share of patients whose tumors shrank by a set amount.
Among patients with RAS G12 mutations, median survival was 13.2 versus 6.6 months and the response rate was 33.2% versus 11.8%. Subgroup analyses at ESMO 2026 reported benefit in the same direction regardless of mutation type, including G12D (hazard ratio 0.49) and G12V (0.32), and regardless of the comparator chemotherapy. On quality-of-life questionnaires, time until overall health status worsened was 5.7 months, compared with 2.6 months in the chemotherapy group.
Side effects and management: skin, mouth and diarrhea care
According to the U.S. prescribing information, the most common side effects were skin reactions such as rash (86%, grade 3 in 10%), diarrhea (63%, grade 3 in 6%) and mouth sores (57%, grade 3 in 9%). Nausea, fatigue, vomiting, abdominal pain, swelling and loss of appetite were also frequent. Gastrointestinal perforation (0.9%) and interstitial lung disease or pneumonitis (2.4%) were uncommon but are listed as warnings.
Knowing about these effects in advance makes them easier to manage. Regular moisturizing and sun protection for the skin, and a soft toothbrush and mouth rinse for oral care, are commonly recommended. If diarrhea continues, discuss anti-diarrheal medicine and fluids with your care team, and report coughing, shortness of breath or severe abdominal pain right away. In the trial, 1.2% of patients stopped the drug because of treatment-related side effects (11.2% with chemotherapy). When side effects occur, doctors adjust by lowering the dose or pausing treatment. Effective contraception is needed because the drug may harm a fetus.
Where it is available: approved in the U.S., recommended in Europe
- United States: approved by the FDA on August 26, 2026 and now prescribed (approved treatment).
- Europe: on October 15, 2026, the European Medicines Agency's CHMP issued a positive opinion. The European Commission makes the final decision.
- Canada: Health Canada is reviewing the drug in parallel with the FDA through Project Orbis.
- Japan: Japan's Pharmaceuticals and Medical Devices Agency (PMDA) took part in the FDA review as an official observer. The Japan Registry of Clinical Trials (jRCT) lists RASolute 304, a phase 3 trial of daraxonrasib after surgery to help prevent recurrence.
A phase 3 trial in newly diagnosed metastatic pancreatic cancer, RASolute 303, is also under way. In September 2026, the FDA granted breakthrough therapy designation to daraxonrasib combined with gemcitabine and nab-paclitaxel as first-line treatment. Approval scope and insurance coverage differ by country, so if you are considering treatment abroad, check the local approval status and costs first. See other Japan medical information for how to read Japanese medical sources.
What to check and questions for your doctor
- What are my KRAS/RAS test results, and if I have not been tested, can I be tested now?
- At my current stage of treatment, could daraxonrasib or a related clinical trial be an option?
- How should I manage rash and mouth sores, and when should I call the clinic?
- Can I take it with my other medicines?
- Are there hospitals running first-line or post-surgery clinical trials I could join?
Frequently asked questions
Which pancreatic cancer patients can use daraxonrasib?
Under the FDA label, adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy, or who are not candidates for multiagent chemotherapy. The indication does not require a RAS test result.
How effective is the new pancreatic cancer drug daraxonrasib?
In RASolute 302, median overall survival was 13.2 months versus 6.7 months with standard chemotherapy, a 60% lower risk of death. Median progression-free survival was 7.2 versus 3.6 months, and the response rate was 30% versus 11%.
What are the side effects of daraxonrasib?
Rash, diarrhea and mouth sores were common. They are managed with skin and mouth care, anti-diarrheal medicine and dose adjustment; 1.2% of patients stopped the drug due to side effects. Report cough, shortness of breath or severe abdominal pain to your care team right away.
Is daraxonrasib available in Japan?
As of the source check date (2026-10-25), no Japanese approval has been announced. The PMDA observed the FDA review, and a post-surgery phase 3 trial (RASolute 304) is registered in jRCT.
Related: First-Line CLL Treatment: FDA Approves Pirtobrutinib · FDA approves dostarlimab for rectal cancer · All articles by cancer type
Sources
- U.S. Food and Drug Administration — FDA approves daraxonrasib for metastatic pancreatic adenocarcinoma (2026-08-26)
fda.gov
Checked: 2026-10-25 - OncLive — Daraxonrasib meets all primary, key secondary efficacy end points in pretreated PDAC (ASCO 2026, 2026-05-31)
onclive.com
Checked: 2026-10-25 - Revolution Medicines — Overall survival data for RASONQUE (daraxonrasib) across subgroups in previously treated metastatic pancreatic cancer at ESMO 2026 (2026-10-23)
globenewswire.com
Checked: 2026-10-25 - OncLive — CHMP recommends approval of daraxonrasib for previously treated metastatic pancreatic cancer (2026-10-15)
onclive.com
Checked: 2026-10-25 - ClinicalTrials.gov — NCT06625320: RASolute 302, daraxonrasib versus standard chemotherapy in previously treated metastatic PDAC
clinicaltrials.gov/study/NCT06625320
Checked: 2026-10-25 - Japan Registry of Clinical Trials (jRCT) — jRCT2031250809: RASolute 304, adjuvant daraxonrasib in resected pancreatic ductal adenocarcinoma
jrct.mhlw.go.jp
Checked: 2026-10-25
Written by the FTH editorial team. Sources checked 2026-10-25 · Medical review: not applicable
This article is general information based on public sources and does not replace diagnosis or treatment. Please discuss treatment decisions with your medical team.
