EMA recommends authorisation of Rasonque for metastatic pancreatic cancer

EMA’s human medicines committee (CHMP) has recommended granting a marketing authorisation in the European Union for Rasonque (daraxonrasib), an oral treatment for adults with metastatic pancreatic adenocarcinoma (pancreatic cancer that has spread) who have received at least one previous treatment.

People with metastatic pancreatic adenocarcinoma whose disease has worsened after prior treatment have limited treatment options and a poor prognosis. Given the seriousness of the disease, the limited efficacy and substantial toxicity of standard-of-care chemotherapy, there is a need for better treatment options for these patients.

EMA’s recommendation follows a phased review of data on Rasonque, which was identified under EMA’s Cancer Medicines Pathfinder project as a high-priority medicine that could address this unmet medical need.

The phased review allowed CHMP to start the assessment several months before the anticipated submission of the complete application. During the review, which started in early July 2026, the CHMP evaluated the data (quality, non-clinical and clinical) in phases, as they were submitted by the company. This approach shortened the assessment time to less than 150 days, while maintaining the standards for quality, safety and effectiveness. By comparison, a standard evaluation can take up to 210 active days and usually takes around a year overall, including time for the company to respond to questions.

The lessons learnt from the phased review of Rasonque will help inform the implementation and strengthened use of phased reviews under the EU’s new pharmaceutical legislation. In this context, the phased review is foreseen as a tool to allow a more agile, streamlined evaluation of medicines, which would ultimately lead to earlier patient access to promising treatments.