EMA recommends approval of Revolution's pancreatic cancer drug
The EMA medicines committee recommended marketing authorization for RASONQUE (daraxonrasib); the European Commission still must decide.
TL;DR
- The EMA committee recommended EU marketing authorization for Revolution Medicines’ RASONQUE (daraxonrasib).
- The recommendation covers adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy.
- A committee opinion is not final European Commission authorization, and the reports do not replace review of the full clinical evidence.
The European Medicines Agency’s medicines committee recommended marketing authorization for Revolution Medicines’ RASONQUE, also known as daraxonrasib. Reuters and Pharmaphorum reported the committee’s positive opinion on October 15. [1] [2]
The company says the proposed indication is for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy. It said the recommendation followed review of the phase 3 RASolute 302 trial. [1] [3]
The milestone is a committee recommendation, not a final authorization. A European Commission decision is still required, and accessible news coverage does not provide a full independent appraisal of trial data. [1] [2] [3]
The regulatory path and any eventual product information remain to be confirmed. The recommendation does not establish availability, reimbursement or outcomes outside the studied population. [1] [2]
Why it matters
The committee opinion is a step toward potential EU authorization for a late-stage pancreatic cancer therapy. The final regulatory decision and authorized indication remain pending.
Editor's note
Keeps the CHMP recommendation distinct from final European Commission authorization; no treatment advice.