💊 EMA announces Phased Review for daraxonrasib

 

On 7 July 2026, the EMA announced a Phased Review for daraxonrasib (Revolution Medicines) for the treatment of metastatic pancreatic adenocarcinoma. The review is based on data from the Phase III RASolute 302 study, which reported an approximately 60% reduction in the risk of death. 🧬

 

🚀 This marks the first time the EMA has applied the Phased Review approach outside the context of a pandemic-related emergency.

Under this procedure, data are assessed progressively as they become available. The process is expected to be shorter than a standard evaluation, as parts of the assessment can be conducted before the complete MAA has been submitted.

 

❓ What does this mean for EU HTA and the JCA?

From an EU HTA perspective, it will be important to monitor how this accelerated regulatory pathway interacts with the JCA, as a Phased Review does not follow the standard regulatory timelines.

 

📌 Potential Precedent

Daraxonrasib is therefore particularly relevant from an HTA perspective as a procedural precedent: it may represent one of the first cases in which an EMA Phased Review and a JCA intersect. How this interaction will be managed has not yet been fully established and should therefore be closely monitored. 🔍

 

👀 Outlook

Looking ahead, under the new provisions of the reformed EU pharmaceutical legislation, the EMA, in agreement with the CHMP, will consider further medicines under development for Phased Review where this approach is feasible and expected to accelerate the assessment process.