EMA recommends authorisation for Revolution Medicines' Rasonque (daraxonrasib)
- CHMP recommended EU marketing authorisation for Rasonque (daraxonrasib) for adults with metastatic pancreatic adenocarcinoma after at least one prior treatment.
- A phased review under the Cancer Medicines Pathfinder shortened assessment to under 150 active days versus up to 210 active days in a standard review.
- Phase 3 (n=500; 92% with RAS G12 mutation) showed median overall survival 12.4 months with daraxonrasib versus 6.7 months with chemotherapy, and median PFS 7.2 versus 3.6 months.
- Common adverse reactions included diarrhoea, rash, stomatitis, nausea and vomiting; daraxonrasib is a RAS inhibitor that binds cyclophilin A to block RAS activity.
Recommendation and target population
EMA’s human medicines committee (CHMP) has recommended a marketing authorisation in the EU for Rasonque (daraxonrasib), an oral treatment for adults with metastatic pancreatic adenocarcinoma whose disease progressed after at least one prior systemic treatment. The recommendation recognises a significant unmet need given limited efficacy and substantial toxicity of standard‑of‑care chemotherapy in this setting.
Phased review and regulatory context
The application was assessed through a phased review under EMA’s Cancer Medicines Pathfinder, with the CHMP evaluating quality, non‑clinical and clinical data as they were submitted. The approach reduced assessment time to less than 150 active days. Lessons from this review will inform use of phased reviews under the EU’s new pharmaceutical legislation to accelerate access to promising treatments.
Clinical evidence and safety
Daraxonrasib is a RAS inhibitor that binds cyclophilin A to form a complex that blocks RAS proteins. In an open‑label phase 3 multinational study of 500 patients (92% with confirmed RAS G12 mutations), median overall survival was 12.4 months with daraxonrasib versus 6.7 months with chemotherapy; median progression‑free survival was 7.2 versus 3.6 months. Data cut‑offs: overall survival to 15 June 2026 and PFS to 10 February 2026. Common adverse events included diarrhoea, rash, stomatitis, nausea and vomiting.
Next steps
The CHMP opinion will be sent to the European Commission for a fast‑track decision on EU‑wide marketing authorisation. If authorised, pricing and reimbursement decisions will be taken by individual Member States. The applicant is Revolution Medicines; daraxonrasib received orphan designation for pancreatic cancer on 20 April 2026. Daraxonrasib also falls under the EU Health Technology Assessment Regulation, with a separate joint clinical assessment process.
Source: EMA