Rasonque moves closer to EU approval for pancreatic cancer, halving the risk of death

Mark A. Goldsmith, Revolution Medicines’ chief executive and chairman, led the company’s development of Rasonque, a once-daily oral RAS inhibitor for adults with metastatic pancreatic adenocarcinoma. The treatment is intended for patients who have already received at least one systemic therapy.

The US Food and Drug Administration approved Rasonque in August through its Commissioner’s National Priority Voucher programme. Angelo de Claro, director of the FDA’s Oncology Center of Excellence, said the early approval reflected “unprecedented results in an area of high unmet need.”

Those results came from the Phase 3 RASolute 302 trial, which enrolled patients with metastatic pancreatic adenocarcinoma after at least one previous systemic treatment and included several KRAS mutation subtypes. Across the full study population, Rasonque reduced the risk of death by 60% compared with chemotherapy. Median overall survival was 13.2 months with Rasonque and 6.7 months with chemotherapy, with a hazard ratio of 0.40 (95% CI 0.30–0.53).

The trial met its primary and key secondary endpoints with statistically significant and clinically meaningful improvements regardless of tumour RAS mutation status. It also produced a 33% objective response rate across all KRAS mutations.

For patients, the variation between mutation groups is central. People with G12V mutations, who made up 36% of trial participants, had a 50% objective response rate. Those with G12D mutations accounted for 43% of the trial population and had a 24% response rate. G12D mutations represent the largest share of pancreatic cancer patients, while Rasonque produced worse results among people with G12R mutations.

A 321-page FDA review document set out those differences in tumour response. The agency nevertheless extended the approved use to patients unable to receive multiagent systemic chemotherapy, a first-line group that was not enrolled in the pivotal trial. The FDA cited the overall survival benefit, limited alternatives and the difficulty of drawing conclusions from small subgroup analyses in supporting broader use. Revolution Medicines shares fell 6% Thursday after the review documents were released.

On October 15, 2026, Rasonque received a positive opinion from CHMP recommending European Union marketing authorisation for metastatic pancreatic cancer. The recommendation followed an expedited phased review through the European Medicines Agency’s Cancer Medicines Pathfinder project, which considered the drug’s potential to meet a high unmet medical need.

The European Commission must still decide whether to grant final marketing authorisation. If it does, Rasonque would become the first broad RAS-targeted option in the European Union for adults with metastatic pancreatic adenocarcinoma. The prospect matters in a disease with a five-year survival rate of just 13%.

Revolution Medicines describes itself as a global commercial-stage oncology company focused on medicines for patients with RAS-addicted cancers. For European patients, the central question will be whether a broad approval can be translated into treatment decisions that reflect the very different responses seen across KRAS mutations.