EMA backs Revolution Medicines' Rasonque for pancreatic cancer after a sub-150-day review

The European Medicines Agency's human medicines committee (CHMP) recommended on 15 October 2026 that Revolution Medicines' oral RAS inhibitor Rasonque (daraxonrasib) be authorised in the EU for adults with metastatic pancreatic adenocarcinoma who have had at least one previous treatment ¹. The assessment took less than 150 days because the agency reviewed the data in phases as the company submitted them ¹.

What the trial found

The recommendation rests on an open-label, multinational phase 3 study of 500 patients whose metastatic disease had progressed after prior systemic treatment ¹. In that population, 92% carried a confirmed RAS G12 mutation, the group that includes the mutations most often seen in this cancer ¹.

Median overall survival was 12.4 months on Rasonque against 6.7 months on chemotherapy ¹. Median progression-free survival was 7.2 months against 3.6 months ¹. The survival analysis used data collected up to 15 June 2026, and the progression-free analysis used data up to 10 February 2026 ¹. EMA lists diarrhoea, rash, stomatitis, nausea and vomiting as the most common side effects ¹.

Daraxonrasib works by binding cyclophilin A, and the resulting complex attaches to RAS proteins and blocks their activity ¹. RAS mutations leave those proteins permanently switched on in pancreatic adenocarcinoma, which drives uncontrolled cell growth ¹. The drug received EU orphan designation for pancreatic cancer on 20 April 2026 ¹.

What it means for the market

The process matters as much as the product. EMA picked Rasonque under its Cancer Medicines Pathfinder project as a high-priority medicine for an unmet need, which let the CHMP begin assessing quality, non-clinical and clinical data from early July 2026, several months before the full application was due ¹. EMA contrasts that with a standard evaluation, which can run to 210 active days and usually takes about a year once company response time is included ¹.

EMA says the lessons from this review will inform how phased reviews are used under the EU's new pharmaceutical legislation, where the tool is intended to give a faster, more streamlined evaluation ¹. It also says it will consider other medicines for phased review case by case, judged on whether they meet an unmet need and are of major public health interest, particularly for therapeutic innovation ¹. For regulatory affairs teams with oncology assets in areas of high need, that is an opening worth planning around: data packages that can be submitted in tranches may now shorten time to an EU opinion.

Access will still depend on national decisions. Price and reimbursement are set by each member state once the Commission grants authorisation ¹. Daraxonrasib also falls under the EU Health Technology Assessment Regulation, so it faces a joint clinical assessment run by the HTA Secretariat within the European Commission, separate from EMA's review ¹. Market access teams will therefore be working to two European processes alongside national pricing talks.

Caveats

The main study was open-label rather than blinded ¹. The progression-free survival data are older than the survival data, with a cut-off four months earlier ¹. EMA's statement does not give results separately for patients without a RAS G12 mutation, who made up a small share of those enrolled ¹.

The CHMP opinion is an intermediate step. It now goes to the European Commission, which will fast-track its decision on an EU-wide marketing authorisation ¹.