A Phase 3 trial reported median overall survival of 12.4 months with Rasonque and 6.7 months with chemotherapy, results cited in an EU committee’s recommendation for the drug.
On Oct. 15, the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) recommended Revolution Medicines’ Rasonque (daraxonrasib) as a single-agent treatment for adults with metastatic pancreatic adenocarcinoma who have received at least one systemic treatment.
EMA based its positive opinion on RASolute 302, a Phase 3 trial involving 500 patients whose cancer had progressed after systemic treatment. Median progression-free survival — the time before disease worsens — was 7.2 months with Rasonque and 3.6 months with chemotherapy, the agency said. EMA also reported that 92% of participants had a confirmed RAS G12 mutation.
Diarrhea, rash, stomatitis (inflammation of the lining of the mouth), nausea and vomiting were among the treatment’s most common side effects listed by EMA. The agency cited limited treatment options for patients and said standard chemotherapy has limited efficacy and substantial toxicity.
EMA said the phased review began in early July 2026 and concluded in less than 150 days. A conventional evaluation can include up to 210 active days and generally takes about a year overall, the agency said.
The committee’s opinion goes to the European Commission for an EU-wide authorization decision. EMA said that decision will be fast-tracked. If the Commission authorizes Rasonque, member states will decide pricing and reimbursement individually.
