The European Medicines Agency has started a phased review of daraxonrasib, a medicine intended for the treatment of metastatic pancreatic cancer, in an effort to accelerate access for patients with few remaining options.
A phased review allows the CHMP to evaluate quality, nonclinical, and clinical data as they become available, rather than waiting for a complete marketing authorisation application. The approach is expected to shorten the overall assessment timeline while maintaining the same standards for quality, safety, and efficacy as any other medicine.
The review was triggered by a phase 3 study comparing daraxonrasib with chemotherapy in patients with metastatic pancreatic cancer whose disease had progressed after prior treatment. People in this position have very limited treatment options and a poor prognosis, with a life expectancy of about six months, creating a significant unmet medical need.
Daraxonrasib was recognised as a high priority under EMA’s Cancer Medicines Pathfinder project based on its potential to address this need, and its eligibility for a centralised marketing authorisation application was expedited accordingly.
The review of daraxonrasib will also serve as a test case for the reformed EU pharmaceutical legislation, which is expected to strengthen the use of phased reviews. The political agreement on the reform — the most significant overhaul of the EU regulatory framework in over two decades — was reached in December 2025 and is expected to enter into force in 2026, with full applicability by 2028. The legislation aims to modernise how medicines are developed, authorised, and made available across the EU, with phased reviews positioned as a tool for more agile and streamlined evaluation that could ultimately lead to earlier patient access to promising treatments.
The overall review timeline for daraxonrasib cannot be anticipated, but the process is expected to be shorter than a regular evaluation since part of the assessment will be completed before the full application is submitted. EMA, in agreement with the CHMP, will consider further medicines for phased review on a case-by-case basis, guided by unmet medical need and public health impact.
Source: EMA News
