The European Medicines Agency‘s (EMA) Committee for Medicinal Products for Human Use (CHMP) on October 15 recommended granting an EU marketing authorisation for Rasonque (daraxonrasib), an oral RAS inhibitor, for adults with metastatic pancreatic adenocarcinoma whose disease has worsened after at least one prior treatment. The opinion came after a phased review that the agency said took under 150 days, and it now goes to the European Commission for a fast-tracked decision.

Daraxonrasib, developed by Revolution Medicines, binds to a protein called cyclophilin A; the resulting complex attaches to RAS proteins and blocks their activity, according to the EMA’s announcement. Mutated RAS proteins stay switched on and drive uncontrolled cancer cell growth. The EMA described the target population as patients with “limited treatment options and a poor prognosis.”

The trial

The recommendation rests on an open-label, multinational phase 3 study of about 500 patients whose disease had progressed after prior systemic therapy, 92% of whom had a confirmed RAS G12 mutation. Patients received daraxonrasib or chemotherapy. Median overall survival was 12.4 months with daraxonrasib versus 6.7 months with chemotherapy, and median progression-free survival was 7.2 months versus 3.6 months, the EMA said. The survival data run to a cut-off of June 15, 2026, and the progression data to February 10, 2026.

The company’s announcement of the opinion, as reported by OncoDaily, names the trial as RASolute 302 and gives the primary analysis, presented at the 2026 American Society of Clinical Oncology meeting and published in the New England Journal of Medicine: median overall survival of 13.2 versus 6.7 months, a hazard ratio of 0.40, and progression-free survival of 7.2 versus 3.6 months, hazard ratio 0.49. A later survival analysis, with a hazard ratio of 0.49, gave the 12.4-month figure the EMA cites. The most common side effects were diarrhoea, rash, stomatitis, nausea and vomiting, according to the agency; the company’s announcement puts diarrhoea at 63.1% of patients, acneiform dermatitis at 62.4% and stomatitis at 55.5%, with serious adverse reactions in 30% and permanent discontinuation in 2.9%.

How the review was done

Rasonque was identified as a high-priority medicine under the EMA’s Cancer Medicines Pathfinder project and assessed through a phased review that began in early July 2026, in which data were submitted and evaluated in stages before the full application. The agency said the assessment took under 150 days, compared with up to 210 active days for a standard evaluation, and that it will consider phased review for other medicines case by case. The drug received orphan designation for pancreatic cancer on April 20, 2026. In the United States, the FDA approved daraxonrasib on August 26, 2026, for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multiagent therapy, OncoDaily reported.

The opinion was one of six positive recommendations for new medicines at the committee’s October 12 to 15 meeting, according to the meeting highlights, alongside Eli Lilly’s oral GLP-1 drug Foundayo (orforglipron), Yuviwel (navepegritide) for achondroplasia, Kizfizo (temozolomide) for glioblastoma and malignant glioma, and two biosimilars, Fovlussea (ranibizumab) and Neuzafy (filgrastim). The committee also recommended making the naloxone nasal spray Nyxoid available without a prescription for suspected opioid overdose, and confirmed its refusal of Yartemlea (narsoplimab) after a re-examination.

Why it matters

Pancreatic cancer is diagnosed in about 147,000 people in Europe each year, five-year survival remains below 10% and about 80% of patients are diagnosed after the cancer has spread, according to figures in the company’s announcement. The trial’s comparator was chemotherapy, and OncoDaily reported that an EU approval would make daraxonrasib the first broad RAS-targeted option for this population in the bloc. A near-doubling of median survival in a randomized phase 3 trial is the kind of result that changes treatment practice if it holds up outside the trial.

For the EU regulatory system, the case is also a test of the phased-review model, which cut the assessment to under 150 days. “Today’s positive CHMP opinion marks a major step toward making RASONQUE available to eligible adults with metastatic pancreatic cancer in the European Union,” Mark A. Goldsmith, Revolution Medicines’ chief executive and chairman, said in the company statement.

What to watch

The European Commission’s decision, which the EMA said will be fast-tracked; pricing and reimbursement decisions, which fall to individual member states; and a joint clinical assessment under the EU health technology assessment regulation, which the agency said is running separately and is coordinated by the HTA Secretariat.

The caveats

The trial was open-label, so patients and doctors knew which treatment was given. The two survival figures, 13.2 months at the primary analysis and 12.4 months at a later cut-off, come from different analyses of the same study. Side-effect rates are high, with serious adverse reactions in nearly a third of patients. The EMA’s summary is a regulatory opinion, not a peer-reviewed publication, although the primary analysis has been published.

This article is for general information and does not replace advice from a qualified clinician. Corrections: email the editor using the address on the Contact page.