EU backs a pill that nearly doubled survival in metastatic pancreatic cancer

On 15 October 2026 the human medicines committee of the European Medicines Agency (CHMP) recommended granting an EU marketing authorisation for Rasonque (daraxonrasib), an oral RAS inhibitor developed by Revolution Medicines. The recommended use is narrow: adults with metastatic pancreatic adenocarcinoma, the most common form of pancreatic cancer, whose cancer has spread and who have already received at least one systemic treatment. The opinion now goes to the European Commission, which takes the legally binding decision. In the United States the FDA approved it on 26 August 2026, and we covered that decision and the trial behind it in a separate article.

The later survival figure is a little lower, and the gap held

The recommendation rests on RASolute 302, an international, open-label, randomised phase 3 trial in 500 people whose metastatic pancreatic cancer had progressed after earlier treatment. Half were assigned daraxonrasib, half chemotherapy chosen by their doctor. In the trial publication in the New England Journal of Medicine (online 31 May 2026), median overall survival in the whole trial population was 13.2 months with the drug and 6.7 months with chemotherapy, with a hazard ratio of 0.40.

The numbers EMA quotes come from a later analysis, with survival data collected up to 15 June 2026: a median of 12.4 months on daraxonrasib against 6.7 months on chemotherapy. Median progression-free survival, the time people lived without the cancer growing, was 7.2 against 3.6 months, based on data up to 10 February 2026. EMA's public summary does not give a hazard ratio for the later survival analysis.

A median of 12.4 months means that half of the people on the drug lived longer than that and half did not. In a disease where the comparison group's median was under seven months, that is a large difference. It is still a gain measured in months, in people whose cancer had already spread, not a cure.

The outcome is how long people lived

The measured outcome here is how long people lived, not a marker in blood or a result in mice, and it comes from a randomised trial in humans.

The target is also notable. According to the trial authors, oncogenic RAS mutations are present in more than 90% of cases of this cancer, and in the trial 92% of participants had a mutation of the RAS G12 type. As EMA describes it, daraxonrasib first binds a protein inside the cell, cyclophilin A, and the resulting complex attaches to RAS and blocks its signalling.

What the trial does not settle

The trial was open-label: patients and doctors knew who was receiving which treatment.

Side effects were common in both groups. Every patient on daraxonrasib and 97.7% of those on chemotherapy had at least one adverse event after starting treatment; events of grade 3 or higher, meaning severe, occurred in 61.8% and 69.6%. Treatment-related adverse events led to stopping treatment in 1.2% of the daraxonrasib group and 11.2% of the chemotherapy group. EMA lists rash, diarrhoea, inflammation of the lining of the mouth, nausea and vomiting as the most common side effects.

The result applies to one situation: metastatic pancreatic adenocarcinoma after earlier treatment. This trial says nothing about earlier stages of the disease, about treatment as the first therapy, or about other cancers. The trial was funded by Revolution Medicines, and several of its authors are company employees.

Between a recommendation and a pharmacy

EMA calls the committee's opinion an intermediary step. The European Commission is expected to fast-track its decision on an EU-wide authorisation; after that, price and reimbursement are decided separately by each member state, so availability will differ from country to country.

The assessment was unusually fast. EMA began reviewing the data in phases, as the company submitted them, in early July 2026, and the assessment took less than 150 days. A standard evaluation can take up to 210 active days and usually takes around a year overall. The drug received orphan designation for pancreatic cancer on 20 April 2026. Its EU joint clinical assessment of health technologies runs separately from EMA's review.

If you or someone close to you is being treated for metastatic pancreatic cancer, whether this medicine or a clinical trial is an option is a question to discuss with the treating oncologist.

This article is for information only and does not replace a consultation with a doctor. Nothing in it is a recommendation to start, stop or change treatment.

Sources

• O'Reilly EM, Wainberg ZA, Hendifar AE, et al. Daraxonrasib or chemotherapy in previously treated metastatic pancreatic cancer. N Engl J Med. 2026. PMID 42223072

• RASolute 302 trial registration. NCT06625320

• U.S. Food and Drug Administration. FDA approves daraxonrasib for metastatic pancreatic adenocarcinoma. 26 August 2026. fda.gov

• European Medicines Agency. EMA recommends authorisation of Rasonque for metastatic pancreatic cancer. 15 October 2026. ema.europa.eu

• European Medicines Agency. Rasonque: CHMP summary of positive opinion. 15 October 2026. ema.europa.eu