Overview
- The Committee for Medicinal Products for Human Use recommended EU marketing authorisation for Rasonque (daraxonrasib) on Oct. 15, 2026 and the opinion has been sent to the European Commission for a final, fast‑tracked decision.
- A phase 3 study of 500 patients showed median overall survival of 12.4 months with Rasonque versus 6.7 months with chemotherapy and median progression‑free survival of 7.2 months versus 3.6 months, with common side effects including diarrhoea, rash, stomatitis, nausea and vomiting.
- Daraxonrasib is an oral RAS inhibitor that works by binding cyclophilin A to form a complex that attaches to mutant RAS proteins and blocks their signalling, which slows tumour growth and kills cancer cells.
- Revolution Medicines is preparing for a Europe‑wide launch by hiring regulators and commercial staff, pursuing parallel reviews through Project Orbis, and using funding arrangements such as Royalty Pharma to support an independent rollout.
- If the European Commission grants authorisation, access will depend on national price and reimbursement negotiations and an independent EU joint clinical assessment under the HTA rules, and EMA will review whether the orphan designation can be maintained.