MEDISEARCHER NEWS
European Union · Pancreatic cancer · 16 October 2026
In brief
- The European Medicines Agency’s medicines committee has recommended Rasonque (daraxonrasib) for adults with metastatic pancreatic adenocarcinoma who have received at least one previous systemic treatment.
- In the pivotal Phase 3 trial, median overall survival was 12.4 months with daraxonrasib compared with 6.7 months with standard chemotherapy, according to the EMA.
- Median progression-free survival was 7.2 months with daraxonrasib versus 3.6 months with chemotherapy.
- The evidence comes from a randomised Phase 3 trial involving 500 patients and has been published in the New England Journal of Medicine.
- Rasonque is already approved in the United States but is not yet authorised in the European Union. The European Commission must now make the formal marketing-authorisation decision.
- Even after EU authorisation, pricing, reimbursement and routine patient access will be determined separately within individual European countries.
A new targeted treatment for metastatic pancreatic cancer has moved a major step closer to European approval after the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended Rasonque (daraxonrasib) for authorisation.
The positive opinion, adopted on 15 October 2026, covers Rasonque as a monotherapy for adults with metastatic pancreatic adenocarcinoma who have received at least one previous systemic treatment.
The recommendation is supported by a randomised Phase 3 trial involving 500 patients with previously treated metastatic pancreatic cancer. According to the EMA, median overall survival was 12.4 months with Rasonque compared with 6.7 months with standard chemotherapy.
Median progression-free survival — the length of time patients lived without their cancer worsening or death — was 7.2 months with Rasonque compared with 3.6 months with chemotherapy.
The findings are particularly important because metastatic pancreatic cancer remains one of the most difficult cancers to treat and treatment options become increasingly limited after the disease progresses following initial therapy.
However, the CHMP recommendation does not mean Rasonque is already routinely available to patients in Europe. The European Commission must still issue the formal EU marketing authorisation, after which individual countries will make their own pricing and reimbursement decisions.
What has the EMA decided on Rasonque?
On 15 October 2026, the CHMP adopted a positive opinion recommending that Rasonque receive a European Union marketing authorisation.
The recommended indication is:
Rasonque as monotherapy for the treatment of adult patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy.
Pancreatic adenocarcinoma is the most common form of pancreatic cancer. Metastatic disease means the cancer has spread beyond the pancreas to other parts of the body.
Rasonque will be available as 100 mg and 150 mg film-coated tablets if marketing authorisation is granted.
The EMA says treatment should be initiated by physicians experienced in the use of anticancer medicines.
How effective was daraxonrasib in the Phase 3 trial?
The pivotal RASolute 302 study was a randomised, open-label, multicentre Phase 3 trial involving 500 patients whose metastatic pancreatic adenocarcinoma had progressed after previous systemic treatment.
Participants were randomly assigned to receive daraxonrasib or a physician’s choice of standard chemotherapy.
The results showed substantial improvements in both major measures of treatment efficacy reported by the EMA:
- Median overall survival: 12.4 months with Rasonque versus 6.7 months with standard chemotherapy.
- Median progression-free survival: 7.2 months with Rasonque versus 3.6 months with standard chemotherapy.
The Phase 3 findings have also been published in the New England Journal of Medicine, where investigators concluded that daraxonrasib produced significantly longer overall survival and progression-free survival than chemotherapy in previously treated metastatic pancreatic ductal adenocarcinoma.
The results should not be interpreted as meaning that Rasonque will double the life expectancy of every patient. Median survival describes the point at which half the patients in a study group have experienced the relevant outcome and does not predict exactly how long an individual patient will live.
Why is Rasonque important for pancreatic cancer?
Pancreatic cancer has historically been exceptionally difficult to treat, particularly after it has spread to distant parts of the body.
One reason Rasonque is scientifically important is that it targets the RAS signalling pathway.
Abnormal activation of RAS is a central driver of pancreatic ductal adenocarcinoma, with oncogenic RAS mutations present in more than 90% of cases according to the published Phase 3 research.
RAS has long been considered a difficult therapeutic target. The development of medicines capable of directly or indirectly disrupting RAS signalling has therefore become an important area of cancer research.
Daraxonrasib is designed to inhibit multiple forms of RAS rather than targeting only a single specific RAS mutation.
How does daraxonrasib work?
Daraxonrasib is an oral RAS inhibitor.
The medicine binds to a protein called cyclophilin A. The resulting complex interacts with RAS proteins and interferes with the downstream signalling that helps drive cancer-cell growth and survival.
By disrupting this signalling, daraxonrasib is intended to kill cancer cells and slow tumour growth.
This is a different approach from conventional chemotherapy, which generally attacks rapidly dividing cells rather than selectively interfering with a cancer-driving signalling pathway.
Does Rasonque only work for one RAS mutation?
No single RAS mutation is specified in the EU indication recommended by the CHMP.
The Phase 3 programme evaluated daraxonrasib in a broad population of patients with previously treated metastatic pancreatic adenocarcinoma, while efficacy analyses also examined patients with RAS G12 mutations.
This is relevant because several different RAS mutations can occur in pancreatic cancer.
The final European prescribing information, including any testing requirements and detailed recommendations for use, will be published if the European Commission grants marketing authorisation.
What are the side effects of Rasonque?
According to the EMA, the most common side effects reported with Rasonque include:
- rash;
- diarrhoea;
- stomatitis, or inflammation of the lining of the mouth;
- nausea; and
- vomiting.
As with other cancer medicines, the suitability of daraxonrasib for an individual patient depends on factors including the characteristics of the cancer, previous treatment, other medical conditions and the overall benefit-risk assessment made by the treating oncology team.
Is Rasonque already approved in the United States?
Yes.
The US Food and Drug Administration approved Rasonque on 26 August 2026 for adults with metastatic pancreatic adenocarcinoma who have received at least one previous systemic therapy or who are not candidates for multiagent systemic therapy.
The FDA described Rasonque as a first-in-class targeted treatment for metastatic pancreatic cancer.
The US approval means daraxonrasib is no longer simply an experimental cancer medicine globally. Its regulatory status in Europe is different, however, because the EU marketing-authorisation process has not yet been completed.
Is Rasonque approved in the European Union?
Not yet.
A positive CHMP opinion is one of the final major steps in the centralised European medicines approval process, but it is not itself a marketing authorisation. MediSearcher’s EU medicine access guide explains the wider European framework for medicine regulation, prescriptions and access across member states.
The recommendation now goes to the European Commission, which will make the legally binding decision on whether Rasonque can be marketed across the European Union.
The EMA has said the Commission will fast-track its decision.
If marketing authorisation is granted, detailed European product information will then be published, including the final Summary of Product Characteristics and information for patients.
When could Rasonque become available to patients in Europe?
EU marketing authorisation would allow Rasonque to be marketed across the European Union, but it would not automatically make the medicine routinely available or publicly reimbursed in every member state.
Pricing and reimbursement decisions are generally made nationally. MediSearcher’s guide to prescription costs and reimbursement across the EU explains how national reimbursement systems can affect what patients ultimately pay and whether medicines are covered after regulatory approval.
This means access could develop at different speeds in countries including Germany, France, Italy, Spain, Ireland, Sweden, Poland, the Netherlands, Malta and other EU member states.
National health technology assessment bodies and healthcare systems may evaluate the medicine’s clinical benefit, cost effectiveness, budget impact and appropriate place in treatment before deciding whether and under what conditions it should be reimbursed.
Rasonque also falls within the scope of the EU Health Technology Assessment Regulation, according to the EMA, meaning a joint clinical assessment forms part of the wider European assessment landscape while national authorities retain responsibility for pricing and reimbursement.
Why was the European review unusually fast?
Rasonque was identified as a high-priority medicine under the EMA’s Cancer Medicines Pathfinder initiative.
The regulator used a phased review process that allowed assessment of parts of the evidence to begin before the complete marketing-authorisation application had been submitted.
The EMA says the review began in early July 2026 and required less than 150 active assessment days.
A standard evaluation can involve up to 210 active assessment days, with the overall process often taking considerably longer when periods for applicants to answer regulatory questions are included.
The Rasonque assessment is therefore important not only as a pancreatic cancer development but also as an example of efforts to accelerate regulatory assessment of medicines addressing serious diseases and major unmet medical needs.
What happens next?
The next major milestone is the European Commission’s decision on marketing authorisation.
If approval is granted, attention will then shift increasingly towards real-world patient access: launch plans, national health technology assessments, pricing and reimbursement decisions.
Those country-level decisions may ultimately determine when patients in different parts of Europe can actually receive Rasonque through their healthcare systems.
MediSearcher will update this article when the European Commission announces its decision and when significant national reimbursement or patient-access decisions become available.
Reviewed by: Dr Mattias Hagman, PhD
Editorial review: This article was reviewed for source accuracy, clinical-trial context and consistency with MediSearcher’s editorial standards. Information about Rasonque’s European regulatory status, the RASolute 302 Phase 3 results, mechanism of action, safety profile and US approval was checked against European Medicines Agency and US Food and Drug Administration regulatory information and the peer-reviewed Phase 3 publication in the New England Journal of Medicine.
Last reviewed: 16 October 2026
Sources and verification
MediSearcher reviewed the following primary and authoritative sources when preparing this article:
- European Medicines Agency: Rasonque EPAR and CHMP positive opinion, 15 October 2026
- European Medicines Agency: recommendation to authorise Rasonque for metastatic pancreatic cancer
- New England Journal of Medicine: Phase 3 RASolute 302 trial of daraxonrasib versus chemotherapy in previously treated metastatic pancreatic cancer
- US Food and Drug Administration: approval of daraxonrasib for metastatic pancreatic adenocarcinoma, 26 August 2026
MediSearcher provides general information about medicines, cancer treatment, clinical research and healthcare. Rasonque has received a positive CHMP opinion but is not yet authorised for marketing in the European Union. This article does not provide personal medical advice or recommend starting, stopping or changing cancer treatment. Patients should discuss treatment decisions with their oncology team or another appropriately qualified healthcare professional.