RASONQUE Receives Positive CHMP Opinion for Pancreatic Cancer
News related to:Revolution Medicines, Inc · 3 min read
REDWOOD CITY, Calif., Oct. 15, 2026 /CourierPR/ -- The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for RASONQUE (daraxonrasib), an oral once-daily tablet designed to address RAS, the key driver of pancreatic cancer. The positive opinion is based on results from the Phase 3 RASolute 302 trial, which demonstrated a 60% reduction in the risk of death compared to chemotherapy in the overall study population, with statistically significant and clinically meaningful improvements across all primary and key secondary endpoints, regardless of tumor RAS mutation status.
The positive CHMP opinion follows an expedited phased review of RASONQUE under the EMA's Cancer Medicines Pathfinder project, highlighting how innovative regulatory pathways may help bring promising medicines to patients sooner. If approved by the European Commission (EC), RASONQUE would provide the first broad RAS-targeted treatment option in the European Union for adults with metastatic pancreatic adenocarcinoma.
The positive CHMP opinion is based on results from the RASolute 302 trial, a global, randomized Phase 3 study evaluating RASONQUE versus investigator's choice of cytotoxic chemotherapy in patients with previously treated metastatic pancreatic adenocarcinoma. The trial met all primary and key secondary endpoints in both the RAS G12 mutant population and the overall intent-to-treat (ITT) population, which included patients with or without an identified tumor RAS mutation.
In the ITT population, RASONQUE reduced the risk of death by 60% compared to chemotherapy, with a hazard ratio (HR) of 0.40 (95% confidence interval [CI]: 0.30-0.53; p<0.0001). The median overall survival (OS) was 13.2 months (95% CI: 10.0, NE) with RASONQUE compared to 6.7 months (95% CI: 5.8-8.0) for chemotherapy. RASONQUE also showed significant improvements in progression-free survival (PFS) with an HR of 0.49 (95% CI: 0.38-0.64; p<0.0001). The median PFS was 7.2 months (95% CI: 5.7-7.5) with RASONQUE compared to 3.6 months (95% CI: 2.9-4.2) with chemotherapy. Results were generally consistent in the RAS G12 population.
The most common adverse reactions in patients treated with RASONQUE were diarrhea (63.1%), dermatitis acneiform (62.4%), stomatitis (55.5%), nausea (50.8%), vomiting (41.6%), and fatigue (33.2%). The Phase 3 RASolute 302 trial was presented at the 2026 American Society of Clinical Oncology Annual Meeting and published in The New England Journal of Medicine.
Pancreatic adenocarcinoma, or PDAC, is the most common form of pancreatic cancer and among the most lethal malignancies, frequently with a late diagnosis, aggressive biology, and limited responsiveness to available treatments. RAS, a key growth control switch in human cells, is the main driver of pancreatic cancer, which is characterized by excessive RAS signaling. Approximately 147,000 people are diagnosed with pancreatic cancer in Europe each year, and the five-year survival rate remains below 10%.1,2 Because early-stage pancreatic cancer often causes few or no symptoms, approximately 80% of patients are diagnosed after the disease has spread, when treatment options are more limited.
RASONQUE (daraxonrasib) is an oral, RAS(ON) multi-selective, noncovalent, tri-complex inhibitor (TCI), approved by the U.S. FDA for the treatment of adult patients with metastatic PDAC who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy.4 RASONQUE is being investigated through a global Phase 3 registrational program in patients with PDAC and metastatic RAS mutant non-small cell lung cancer (NSCLC).
Outside the U.S., RASONQUE is an investigational agent that has not been approved by any regulatory authority. RASONQUE received orphan medicinal product designation for pancreatic cancer and high-priority status under EMA's Cancer Medicines Pathfinder project based on its potential to address a significant unmet need.
U.S. INDICATION
RASONQUE is indicated for the treatment of adult patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy.