Revolution Medicines' pancreatic cancer pill Rasonque wins EU committee backing

Revolution Medicines' once-daily pill Rasonque has won the backing of the European Medicines Agency's drug committee, which recommended on Thursday that it be authorized in the European Union for adults whose pancreatic cancer has spread and who have already been treated. The European Commission makes the final decision and will fast-track it, the agency said.

What the committee recommended

The European Medicines Agency's human medicines committee, known as the CHMP, adopted a positive opinion on Thursday, Oct. 15, recommending that the European Union authorize Rasonque, Revolution Medicines' daraxonrasib tablet. The recommendation covers use on its own in adults with metastatic pancreatic adenocarcinoma who have already received at least one systemic treatment.

Pancreatic adenocarcinoma is the most common form of pancreatic cancer, according to the company, and metastatic means it has spread. About 147,000 people are diagnosed with pancreatic cancer in Europe each year, and fewer than 10% survive five years, the company said, citing published estimates.

Rasonque would come as 100 mg and 150 mg tablets, and treatment should be started by doctors experienced with cancer medicines, according to the agency. Daraxonrasib blocks RAS proteins, which are involved in cell growth and survival. In pancreatic adenocarcinoma, mutations in the RAS gene leave these proteins permanently switched on, and the drug works by binding a protein called cyclophilin A to form a complex that attaches to RAS and blocks its activity, the agency said.

A faster review than usual

The agency reviewed the data in phases as the company submitted them, starting in early July, after identifying Rasonque as a high-priority medicine under its Cancer Medicines Pathfinder project. That shortened the assessment to less than 150 days. A standard evaluation can take up to 210 active days and usually takes around a year overall, including time for the company to answer questions, the agency said.

What the trial showed

The recommendation rests on RASolute 302, the company's name for an open-label Phase 3 study of 500 patients whose metastatic disease had worsened after earlier treatment. Of those patients, 92% had a confirmed RAS G12 mutation. Patients given Rasonque lived for a median of 12.4 months, compared with 6.7 months for those given chemotherapy, according to the agency. They also went a median of 7.2 months before their disease worsened, against 3.6 months on chemotherapy.

The agency's survival figure uses data collected through June 15, 2026. In the trial's primary analysis, presented at the American Society of Clinical Oncology's 2026 annual meeting, median survival was 13.2 months on Rasonque against 6.7 months on chemotherapy, and the drug reduced the risk of death by 60%, the company said. It described the 12.4-month result as a later, ad hoc analysis.

The most common side effects were diarrhoea, rash, mouth inflammation known as stomatitis, nausea and vomiting, the agency said. In the company's figures, diarrhea affected 63.1% of patients on the drug and an acne-like rash 62.4%.

What happens next

The committee's opinion now goes to the European Commission, which makes the final decision and will fast-track it, the agency said. An approval would apply in all EU member states as well as Iceland, Norway and Liechtenstein, but not in the U.K. or Switzerland, which run their own reviews, according to the company. Prices and reimbursement would then be set country by country.

Daraxonrasib was designated an orphan medicine for pancreatic cancer in April. The agency said it will now review whether that designation can be kept.

What it means for Revolution Medicines

The U.S. Food and Drug Administration approved Rasonque on Aug. 26, 2026, according to the company, which said that if the Commission agrees it would be the first broad RAS-targeted treatment option in the EU for these patients. Revolution Medicines told Reuters it has been expanding its regulatory, medical, market-access and commercial operations in several key European markets, a step the news agency said signals confidence that it can sell the drug there without a local partner. The news agency also cited analyst forecasts of $11.5 billion in peak annual global sales.

Revolution Medicines shares fell 2.2% on Thursday, when the Nasdaq Biotechnology Index rose about 2%. They dropped about 6% on Friday to close at $177.96, as the index fell 2.6%, by TickerGrove's calculation from Nasdaq data.