EMA backs Rasonque for metastatic pancreatic cancer, with median survival of 12.4 months
The EMA's human medicines committee recommended EU authorization of Rasonque, an oral drug for adults with metastatic pancreatic cancer that progressed after prior treatment.
EU committee backs the drug
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended that the European Commission grant an EU-wide marketing authorization for daraxonrasib, sold under the brand name Rasonque. The oral treatment is aimed at adults with metastatic pancreatic adenocarcinoma who have already received at least one earlier treatment and whose disease kept getting worse. The agency describes the opinion as an intermediate step, since the Commission now takes the final decision. Once authorization is granted, each member state will decide on price and reimbursement and on how the drug fits into its national health system. Manufacturer Revolution Medicines markets the drug, which is already authorized in the United States for certain patients under specific conditions.
Trial results
The recommendation rests on an international phase 3 study of 500 patients whose disease had progressed after earlier systemic therapy. In this trial, median survival rose to 12.4 months on daraxonrasib, against 6.7 months for patients given chemotherapy. The gap of 5.7 months amounts to roughly 85% more median survival time. Median progression-free survival on the drug was 7.2 months. A RAS G12 mutation had been confirmed in 92% of participants, and these medians describe the study group as a whole rather than what any single patient can expect.
- Daraxonrasib
- 12.4 months
- Chemotherapy
- 6.7 months
How the drug acts on the tumor
Daraxonrasib belongs to a new class of agents called RAS(ON) inhibitors. RAS encodes a protein that normally switches on briefly to drive cell growth and division, but mutations keep it permanently active. Around 90% of pancreatic cancer cases carry such mutations. The drug binds to cyclophilin A, forming a complex that attaches to RAS proteins and blocks their activity. Unlike earlier inhibitors that target one specific mutation, daraxonrasib acts on several RAS variants.
Matthias Ebert of the German Society for Gastroenterology, Digestive and Metabolic Diseases described the prospects to dpa.
Daraxonrasib opens a window for new treatment options in combination with the substance.
Why pancreatic cancer is so hard to treat
In Germany, about 20,000 people are diagnosed with pancreatic cancer each year, according to the Cancer Information Service and the Robert Koch Institute (RKI). The tumor often causes no clear symptoms in its early stages and is frequently found after it has spread. Only about one in ten patients is still alive five years after diagnosis, according to RKI registry data. Surgical cure is possible only when the tumor is found early and can be removed entirely, which applies to a small share of patients. For metastatic disease, treatment is palliative and aims to extend survival and preserve quality of life.
Review timeline
The EMA assessment began in early July 2026, after the drug had been placed in the agency's Cancer Medicines Pathfinder project as a high-priority therapy. The agency used a staged review, which let the committee start evaluating data several months before the full application was submitted. The committee examined quality, non-clinical and clinical data, and Germany's Federal Institute for Drugs and Medical Devices took part in the process. The US Food and Drug Administration had approved the drug in August, and some patients had already travelled to the United States to obtain it. The CHMP opinion now goes to the European Commission, and the EU-wide decision is still pending.
- EMA starts assessment of daraxonrasib under its staged review
- US FDA approves daraxonrasib
- CHMP adopts positive opinion recommending EU authorization
