Another JCA initiated as daraxonrasib enters EU HTA process alongside EMA phased review

A new Joint Clinical Assessment has been initiated for daraxonrasib, marking the latest application of the EU HTA framework. The assessment begins alongside an accelerated regulatory review, providing early insight into how prioritized medicines are progressing through parallel EU processes.

The Baseline

• A new Joint Clinical Assessment has been initiated for daraxonrasib in metastatic pancreatic adenocarcinoma.
• The assessment is led by IQWiG (Germany) with the Danish Medicines Council as co-assessor.
• The JCA begins alongside an EMA phased review, reflecting prioritization of therapies addressing high unmet need.

Another Joint Clinical Assessment (JCA) has been initiated under the EU HTA Regulation, with Revolution Medicines’ daraxonrasib for metastatic pancreatic adenocarcinoma added to the latest list of ongoing assessments, updated on July 24, 2026. This brings the number of ongoing JCAs to 15 and follows recent developments, including two JCAs discontinued in late June and the endorsement of two assessments in non-small cell lung cancer (NSCLC).

The JCA is being led by the Institute for Quality and Efficiency in Health Care (IQWiG), Germany, with the Danish Medicines Council acting as co-assessor.

Daraxonrasib has been designated an orphan medicinal product in the EU, reflecting the high unmet need in this setting.  The JCA is progressing alongside several regulatory initiatives intended to accelerate the medicine's evaluation. On July 7, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) began a phased review of daraxonrasib, an approach designed to accelerate assessment by evaluating data in stages as they become available. The medicine has also been identified as a high priority under the EMA’s Cancer Medicines Pathfinder initiative, with eligibility for centralized marketing authorization expedited.

Regulatory activity in the US has also accelerated in parallel. On July 22, the FDA accepted the company’s New Drug Application (NDA) for review, with daraxonrasib selected for the FDA Commissioner’s National Priority Voucher pilot program, which is designed to support expedited review of medicines addressing key public health priorities. The FDA has previously granted both Breakthrough Therapy Designation and Orphan Drug Designation for daraxonrasib in previously treated metastatic pancreatic cancer, and has also authorized expanded access for patients in this setting.

Under the EMA’s phased review approach, data on quality, nonclinical and clinical aspects are assessed in stages, ahead of submission of a complete marketing authorization application. While medicines undergoing phased review are subject to the same standards for quality, safety and efficacy as any other product, the approach allows parts of the evaluation to be completed earlier in the process.

The use of phased review in this case is expected to inform future implementation of provisions within the proposed EU pharmaceutical legislation, where expanded use of such approaches is envisaged to support more flexible and streamlined assessment timelines.

Clinical interest in daraxonrasib has been driven by results from the Phase 3 RASolute 302 trial, presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in June and simultaneously published in the New England Journal of Medicine. The study reported “unprecedented” improvements in overall survival and progression-free survival compared with chemotherapy in patients with previously treated metastatic pancreatic cancer, with the data described as potentially “landscape-changing”. The presentation received a standing ovation from more than 9,000 attendees, reflecting the level of clinical interest in a setting with limited treatment options.

This represents another example of how the JCA framework is being implemented in practice, building on a series of recent developments, including the publication of the first JCA reports and early national use of JCA outputs. These developments are beginning to provide a more detailed picture of how regulatory and HTA processes are operating alongside one another.