Revolution Medicines’ RASONQUE(™) (daraxonrasib) Receives Positive CHMP Opinion Recommending Marketing Authorization in European Union for Metastatic Pancreatic Cancer
Key Highlights
- ➤CHMP recommends EU marketing authorization for RASONQUE in metastatic pancreatic cancer
- ➤RASONQUE cut death risk 60% versus chemotherapy in Phase 3 RASolute 302
- ➤Median overall survival reached 13.2 months versus 6.7 months with chemotherapy
- ➤Median progression-free survival was 7.2 months versus 3.6 months with chemotherapy
- ➤EC approval would make RASONQUE the EU’s first broad RAS-targeted treatment
Expert Statements
Mark A. Goldsmith, Chief executive officer and chairman of Revolution Medicines
“Today’s positive CHMP opinion marks a major step toward making RASONQUE available to eligible adults with metastatic pancreatic cancer in the European Union”
Mark A. Goldsmith, Chief executive officer and chairman of Revolution Medicines
“RASONQUE is an oral medicine designed to address RAS, the key driver of pancreatic cancer, and unprecedented results from the Phase 3 RASolute 302 trial demonstrated its potential to benefit patients with this devastating disease”
Mark A. Goldsmith, Chief executive officer and chairman of Revolution Medicines
“Its expedited review under the EMA’s Cancer Medicines Pathfinder project highlights how innovative regulatory pathways may help bring promising medicines to patients sooner”
Mark A. Goldsmith, Chief executive officer and chairman of Revolution Medicines
“We look forward to the EC’s consideration of this CHMP positive opinion as we continue to work with regulatory authorities around the world to pursue additional approvals and broaden access to RASONQUE”
* Recommendation based on results from Phase 3 RASolute 302 trial, which demonstrated a 60% reduction in risk of death compared with 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 * Positive CHMP opinion follows an expedited phased review of RASONQUE under the EMA’s Cancer Medicines Pathfinder project based on its potential to address a high unmet medical need REDWOOD CITY, Calif., Oct. 15, 2026 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (Nasdaq: RVMD), a global, commercial-stage oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers, today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion of RASONQUE (daraxonrasib) once-daily oral tablets as a monotherapy indicated for the treatment of adult patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy. 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.
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