Summary
The EMA’s human medicines committee recommended EU marketing authorisation for Rasonque, an oral treatment for adults with previously treated metastatic pancreatic adenocarcinoma. In a phase 3 study reported by EMA, median overall survival was 12.4 months with Rasonque and 6.7 months with chemotherapy.
The European Medicines Agency’s human medicines committee (CHMP) has recommended granting EU marketing authorisation to Rasonque (daraxonrasib), an oral treatment for adults with metastatic pancreatic adenocarcinoma whose disease has worsened after at least one previous treatment. The recommendation follows a phase 3 study in which median overall survival was 12.4 months with Rasonque, compared with 6.7 months with chemotherapy, according to EMA.
The CHMP opinion is an intermediary step, not the final EU authorisation. EMA will send it to the European Commission for a decision on an EU-wide marketing authorisation.
What the phase 3 study found
The multinational, open-label study involved 500 patients with metastatic pancreatic adenocarcinoma whose disease had worsened after prior systemic treatment. EMA reports that 92% had a confirmed RAS G12 mutation, which includes the most common RAS mutations associated with this cancer.
Median overall survival was 12.4 months for patients treated with Rasonque and 6.7 months for those treated with chemotherapy. Median progression-free survival—the time patients lived before their disease worsened—was 7.2 months with Rasonque and 3.6 months with chemotherapy. The overall-survival analysis used data collected up to 15 June 2026; the progression-free-survival analysis used data collected up to 10 February 2026. A median is a midpoint measure, not a prediction of how long an individual patient will live.
Daraxonrasib targets RAS, a family of proteins involved in cell growth and survival. EMA explains that mutations in the RAS gene can leave these proteins persistently active in pancreatic adenocarcinoma. Daraxonrasib binds to cyclophilin A, forming a complex that attaches to RAS proteins and blocks their activity. The most common side effects reported with Rasonque were diarrhoea, rash, stomatitis (inflammation of the mouth lining), nausea and vomiting.
How the review and authorisation proceed
EMA selected Rasonque for a phased review through its Cancer Medicines Pathfinder project, which identified it as a high-priority medicine that could address an unmet medical need. The CHMP began assessing quality, non-clinical and clinical data as the company submitted them, several months before the complete application was anticipated. EMA says this shortened the assessment to less than 150 days. A standard evaluation can take up to 210 active days and usually takes around a year overall, including time for the company to respond to questions.
After the European Commission’s decision, pricing and reimbursement would be considered separately by each EU Member State in the context of its national health system. The CHMP recommendation is therefore an important regulatory step, while the final EU authorisation decision remains pending.