A new treatment for metastatic pancreatic cancer has moved a step closer to patients in Europe, offering encouragement to a community with limited treatment options.

On 15 October 2026, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended EU marketing authorisation for Rasonque (daraxonrasib), developed by Revolution Medicines. The recommendation concerns adults with metastatic pancreatic adenocarcinoma, a form of pancreatic cancer that has spread to other parts of the body, who have received at least one previous systemic treatment. Systemic treatments work throughout the body. [1,2]

The recommendation follows approval by the United States Food and Drug Administration (FDA) on 26 August 2026. A final European Commission decision is still needed before the medicine can be marketed in the EU. [1,3]

How daraxonrasib works

Daraxonrasib is taken by mouth once a day. It targets RAS proteins, which help regulate cell growth. Changes in RAS genes, particularly KRAS, are common in pancreatic cancer and can keep these growth signals switched on. [3–5]

The medicine is designed to block several forms of active RAS, interrupting signals that help cancer cells grow. It belongs to a newer generation of treatments addressing a target that researchers struggled to reach for many years. [4]

Longer survival and more time before symptoms worsen

The international phase 3 RASolute 302 trial compared daraxonrasib with standard chemotherapy in 500 people whose metastatic pancreatic cancer had progressed after previous treatment. [1,5]

The survival figures are from EMA’s latest summary; the pain and quality of life figures were reported earlier from the same trial. [1,6]

These median results describe outcomes across the study groups. They cannot predict how long an individual will live or how they will respond to treatment.

Daraxonrasib can cause side effects, including rash, diarrhoea, inflammation of the mouth lining (stomatitis), nausea and vomiting. It is not a cure for metastatic pancreatic cancer. [1,2]

What happens next for patients in Europe

The positive CHMP opinion is an important milestone, but several steps remain before patients can access it routinely in Europe.

The European Commission will now consider the recommendation and make the final decision on EU marketing authorisation. EMA has said this decision will be fast-tracked. If granted, authorisation will be valid across the EU and in Iceland, Liechtenstein and Norway. [1,8]

National pricing and reimbursement decisions will then determine how the treatment is funded and made available. These processes differ between countries, so availability may vary across Europe. There is currently no confirmed date for access across all European countries. [1]

The recommendation follows EU orphan designation in April 2026, which supports the development of medicines for rare conditions, and an EMA phased review that began in July. This review allowed experts to assess data as they became available, shortening the scientific assessment. [1,7]

Research into earlier treatment continues

The phase 3 RASolute 303 trial is investigating daraxonrasib as a first treatment for metastatic pancreatic cancer. It compares daraxonrasib alone, daraxonrasib combined with gemcitabine and nab-paclitaxel, and those chemotherapy medicines alone. This research will help establish whether the medicine could benefit patients earlier in their treatment. [9]

DiCE will continue to follow developments and advocate for timely and equitable access to effective treatments for people living with digestive cancers across Europe.

References

1. European Medicines Agency. EMA recommends authorisation of Rasonque for metastatic pancreatic cancer. Read source

2. European Medicines Agency. Rasonque — CHMP positive opinion adopted on 15 October 2026. Read source

3. US Food and Drug Administration. FDA approves daraxonrasib for metastatic pancreatic adenocarcinoma. 26 August 2026. Read source

4. Cregg J, Edwards AV, Chang S, et al. Discovery of Daraxonrasib (RMC-6236), a Potent and Orally Bioavailable RAS(ON) Multi-selective, Noncovalent Tri-complex Inhibitor for the Treatment of Patients with Multiple RAS-Addicted Cancers. Journal of Medicinal Chemistry. 2025;68:6064–6083. Read source

5. O’Reilly EM, Wainberg ZA, Hendifar AE, et al. Daraxonrasib or Chemotherapy in Previously Treated Metastatic Pancreatic Cancer. New England Journal of Medicine. 2026;395:325–337. Read source

6. Revolution Medicines. US FDA approves Revolution Medicines’ Rasonque (daraxonrasib), the first broad RAS-targeted medicine in metastatic pancreatic cancer. 26 August 2026. Patient-reported outcomes from RASolute 302. Read source

7. European Medicines Agency. EU/3/26/3227 — orphan designation for treatment of pancreatic cancer. Read source

8. European Medicines Agency. Authorisation of medicines. Read source

9. ClinicalTrials.gov. RASolute 303. NCT07491445. Read source