Trial data showed longer overall survival and progression-free survival. EU authorisation still depends on a decision by the European Commission.
For patients in Spain, routine access remains uncertain. On 15 October 2026, the EMA’s Committee for Medicinal Products for Human Use, or CHMP, adopted a positive opinion recommending Rasonque, or daraxonrasib, as a single-agent treatment for adults with metastatic pancreatic adenocarcinoma after at least one previous systemic treatment. The recommendation followed a phased review under the EMA’s Cancer Medicines Pathfinder initiative.
The European Commission must now decide whether to grant marketing authorisation. The CHMP opinion is a recommendation, not final EU approval. Even if the Commission authorises the drug, national procedures will determine when it becomes available in Spanish hospitals. Separate decisions will govern funding through the Sistema Nacional de Salud.
The recommendation draws on RASolute 302, an international phase III trial that was open-label. It enrolled 500 people whose metastatic pancreatic adenocarcinoma had progressed after systemic treatment. In the primary analysis, median overall survival was 13.2 months with daraxonrasib, compared with 6.7 months with chemotherapy chosen by the investigator. The reported hazard ratio for death was 0.40, with a 95% confidence interval of 0.30 to 0.53 and p<0.0001. That corresponds to a 60% reduction in the risk of death. Median progression-free survival was 7.2 months versus 3.6 months. The hazard ratio for progression or death was 0.49, with a 95% confidence interval of 0.38 to 0.64.
A subsequent ad hoc overall-survival analysis reported median survival of 12.4 months with Rasonque and 6.7 months with chemotherapy. The hazard ratio was 0.49, with a 95% confidence interval of 0.39 to 0.62. These figures come from different analyses. In the subsequent analysis, 53.2% of patients in the daraxonrasib group were alive at 12 months, compared with 17.3% in the chemotherapy group. The trial assigned 248 patients to daraxonrasib and 252 to chemotherapy.
Daraxonrasib acts on RAS proteins, which are involved in processes that support the growth and survival of some cancer cells. Its developer describes it as an oral inhibitor of mutant KRAS G12D; the EMA describes Rasonque as an oral treatment. Patients would take it as tablets under the supervision of oncology specialists.
The proposed use covers adults with metastatic pancreatic adenocarcinoma after at least one systemic treatment. It is not a recommendation for every person with pancreatic cancer. Adenocarcinoma is the most common form of pancreatic cancer. Metastatic disease means the cancer has spread beyond the pancreas. Treatment options can be limited when the disease progresses after chemotherapy or another treatment.
The EMA had placed daraxonrasib among high-priority medicines under its Cancer Medicines Pathfinder initiative, which focuses on treatments addressing major medical needs. The CHMP’s phased review let assessors examine scientific documents and clinical results as they became available. The AEMPS said this was the first medicine to receive a positive recommendation through that process.
The review took less than 150 days. It began in July 2026. The agency assessed quality and safety data before reviewing efficacy, while retaining the scientific requirements used in conventional evaluations. A separate line of cancer research was covered in an AI mammography report, which described preliminary findings on risk estimates for women screened by mammogram.
Rashes and diarrhoea were among the most frequent adverse effects identified during clinical research. Researchers also identified inflammation of the mouth’s lining. Nausea and vomiting were frequent as well. The EMA considered the observed benefits sufficient to recommend authorisation for the proposed group. Specialists would make the final treatment decision based on each patient’s condition and alternatives.
There is no confirmed date for routine access in Spain. The European Commission’s decision is the next regulatory step. Hospital availability would depend on further national procedures.
