Amsterdam: The European Medicines Agency’s human medicines committee has recommended Rasonque pancreatic cancer treatment for approval, giving patients with metastatic disease a new option after at least one earlier therapy. The CHMP backed the medicine, also known as daraxonrasib, at its meeting of 12 to 15 October 2026, and the agency announced the opinion on 15 October.
Revolution Medicines Netherlands B.V. is the applicant. The Rasonque pancreatic cancer application targets metastatic pancreatic adenocarcinoma, one of the hardest cancers to treat, and the committee reviewed it through a phased procedure. That route started in early July 2026 and finished in less than 150 days, compared with up to 210 active days for a standard evaluation. The medicine had received orphan designation for pancreatic cancer on 20 April 2026.
The evidence comes from an open-label phase 3 study run in several countries with 500 patients. Some 92 percent of them had a confirmed RAS G12 mutation. Median overall survival reached 12.4 months with Rasonque, against 6.7 months for patients on chemotherapy. Median progression-free survival came in at 7.2 months, compared with 3.6 months for the chemotherapy group.
Those figures explain why oncologists will watch the Rasonque pancreatic cancer opinion closely. Survival that almost doubles in a disease with few treatment choices is rare, and the RAS mutation targeted by the drug is common in this tumour type. The committee also noted the safety profile. The most frequent side effects were diarrhoea, rash, stomatitis, nausea and vomiting, which clinicians will need to manage during treatment.
The Rasonque pancreatic cancer recommendation was one of six new medicines endorsed at the October meeting. Alongside five extensions of indication, it brings the committee’s 2026 total to 72 positive opinions on new medicines, with 8 negative opinions and 10 withdrawals so far this year. The agency, based in Amsterdam, did not record a single negative opinion on a new medicine at this meeting.
A CHMP opinion is not yet a licence for Rasonque pancreatic cancer patients. The European Commission takes the legally binding decision, and it usually does so within about two months of the committee’s opinion. A positive decision would give Rasonque a marketing authorisation valid in all 27 member states, which would open the way to national pricing and reimbursement talks.
That second step will decide how quickly patients benefit. Each member state negotiates price and reimbursement for itself, so access can differ widely between capitals even after EU authorisation. The gap between approval and bedside availability is where promising medicines can lose months, and pancreatic cancer patients have little time to spare.
The speed of the review offers one lesson for regulators. The phased procedure let the agency examine data as it arrived rather than waiting for a complete dossier, and it shortened the assessment by weeks. If the Commission confirms the opinion, Rasonque pancreatic cancer care in Europe will gain a targeted option beyond chemotherapy, and the shortened review gives regulators a model they may reuse for other serious diseases.
