EMA committee backs Revolution Medicines' Rasonque for metastatic pancreatic cancer

The European Medicines Agency's human medicines committee on Oct. 15 recommended granting an EU marketing authorization for Revolution Medicines' Rasonque (daraxonrasib), an oral RAS inhibitor for adults with metastatic pancreatic adenocarcinoma who have already received at least one systemic therapy. The positive opinion from the Committee for Medicinal Products for Human Use (CHMP), adopted in Amsterdam less than two months after the U.S. Food and Drug Administration approved the drug, now goes to the European Commission for a fast-tracked final decision.

Disease and technology background

Pancreatic ductal adenocarcinoma remains one of the hardest solid tumors to treat. Revolution Medicines, citing European data, says about 147,000 people are diagnosed with pancreatic cancer in Europe each year, roughly 80% are diagnosed after the disease has spread, and five-year survival is below 10%. Patients whose disease progresses after first-line chemotherapy have few options, and EMA noted the substantial toxicity of standard second-line chemotherapy in its summary.

RAS mutations drive the large majority of pancreatic tumors. For decades the RAS protein family was considered undruggable, and the first approved KRAS inhibitors targeted only the G12C variant, which is rare in pancreatic cancer. Daraxonrasib takes a different approach. The company describes it as a RAS(ON) multi-selective, noncovalent tri-complex inhibitor: the drug binds the chaperone protein cyclophilin A, and that complex then attaches to RAS in its active state and blocks signaling. In RASolute 302, 92% of enrolled patients had a confirmed RAS G12 mutation, according to EMA, but the trial also met its endpoints in the broader intent-to-treat group that included patients without an identified RAS mutation.

Median progression-free survival was 7.2 months versus 3.6 months for chemotherapy. EMA cited a later data cut showing median overall survival of 12.4 months versus 6.7 months. The most common side effects in the EU summary were diarrhea, acneiform dermatitis, stomatitis, nausea and vomiting. Results were presented at the 2026 ASCO Annual Meeting and published in The New England Journal of Medicine.

Industry implications

The opinion confirms that a pan-RAS strategy can clear the two largest Western regulators within weeks of each other, which raises the bar for every company pursuing mutant-selective KRAS programs. A regimen that works across RAS G12 variants, and in patients without a confirmed mutation, simplifies prescribing in a disease where tissue samples are often scarce and testing turnaround can delay treatment.

The regulatory path is also notable. EMA said the phased review, built on its Cancer Medicines Pathfinder project, let it complete the assessment in under 150 days. The agency said it will consider other medicines for phased review case by case. For oncology developers, that offers a template for narrowing the gap between U.S. and EU approvals; in this case the two decisions came less than two months apart.

Rasonque will also test the EU Health Technology Assessment Regulation. EMA said a joint clinical assessment is running in parallel, coordinated by the HTA Secretariat. The outcome will shape how quickly national payers in Germany, France, Italy and Spain move to reimbursement.

Competitive and supply chain implications

Revolution Medicines, based in Redwood City, California, now has regulatory momentum in two major regions for its oral RAS(ON) inhibitor, while other developers pursue their own KRAS and pan-RAS candidates. The company is extending its lead with the Phase 3 RASolute 303 trial in first-line pancreatic cancer and RASolute 309, which pairs daraxonrasib with its G12D-selective inhibitor zoldonrasib. It is also running Phase 3 work in RAS-mutant non-small cell lung cancer.

The company's release does not describe European manufacturing arrangements or a launch plan. As a small-molecule tablet, daraxonrasib avoids the cold-chain and capacity constraints that complicate biologics and cell therapies, but a European rollout will require distribution partners, pharmacovigilance infrastructure and country-by-country market access teams. The label's management requirements, including dermatologic prophylaxis and attention to CYP3A and P-gp drug interactions, will also put weight on oncologist education and companion supportive-care supplies.

Regional implications

For Europe, the opinion signals that the agency can match the FDA's pace on high-priority cancer medicines when it uses expedited tools. Once the Commission acts, eligible patients in 30 countries could gain access, subject to national reimbursement. The authorization would not extend to the United Kingdom or Switzerland, which run separate approval processes, leaving the company to file there independently.

In the United States, where the drug is already marketed, the EU decision broadens the global evidence base and supports wider international uptake. Countries in Asia-Pacific and Latin America that often reference FDA and EMA decisions may now see filings follow more quickly.

What comes next

• European Commission decision on the EU-wide marketing authorization, which EMA said will be fast-tracked.
• Completion of the EU joint clinical assessment under the Health Technology Assessment Regulation.
• National pricing and reimbursement negotiations across EU member states.
• Data from the Phase 3 RASolute 303 first-line trial and progress in RASolute 309 with zoldonrasib.
• Separate regulatory filings in markets outside the centralized EU procedure, including the United Kingdom and Switzerland.

Sources

• European Medicines Agency: EMA recommends authorisation of Rasonque for metastatic pancreatic cancer
• Revolution Medicines: RASONQUE (daraxonrasib) receives positive CHMP opinion

Image: Vivaldi building, headquarters of the European Medicines Agency in Amsterdam, by Ceescamel via Wikimedia Commons, CC BY-SA 4.0. Cropped and edited by Credence Research.