The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has initiated a phased review of data for daraxonrasib, a medicine being developed for the treatment of metastatic pancreatic cancer. The phased review mechanism is intended to speed up the overall assessment process by allowing regulators to evaluate submitted data in stages as it becomes available, rather than waiting for a complete application package. By adopting this approach, EMA aims to streamline the evaluation timeline while maintaining the same regulatory standards applied to all medicines. The decision to launch the phased review follows the availability of results from a phase 3 clinical study that compared daraxonrasib with chemotherapy in patients with metastatic pancreatic cancer who had previously received treatment. The study formed the basis for EMA’s decision to begin assessing the medicine through the phased review pathway.
Patients with metastatic pancreatic cancer whose disease continues to progress after earlier treatment currently face very limited therapeutic options and generally have a poor prognosis, with a life expectancy of around six months. This situation represents a significant unmet medical need, making the development of new treatment options particularly important.
In recognition of its potential to address this challenge, daraxonrasib has been identified as a high-priority medicine under EMA’s Cancer Medicines Pathfinder project. As a result, the medicine qualified for an expedited assessment of its eligibility for a centralised marketing authorisation application. To further accelerate the regulatory process, the CHMP agreed to examine quality, nonclinical, and clinical data in a phased approach as they are submitted, ahead of the complete marketing authorisation application submission. This phased assessment is expected to support a more efficient review while ensuring that every aspect of the medicine continues to meet established standards for quality, safety, and efficacy.
Phased Review Expected to Support Faster Regulatory Evaluation
According to EMA, the review of daraxonrasib will also serve as an example of how certain provisions within the reformed EU pharmaceutical legislation could strengthen the future use of phased reviews. The updated legislative framework envisions phased reviews as a practical tool for creating a more agile and streamlined evaluation process for medicines with the potential to address major public health needs.
Although EMA noted that the total review timeline for daraxonrasib cannot yet be predicted, the agency expects the process to be shorter than a conventional evaluation because part of the scientific assessment will already have been completed before the full marketing authorisation application is filed.
Looking ahead, EMA, in agreement with the CHMP, plans to consider additional medicines under development for phased review whenever this regulatory pathway is considered feasible and likely to accelerate assessment. Decisions will continue to be made on a case-by-case basis, taking into account whether a medicine is expected to address an unmet medical need and whether it represents a significant public health interest, particularly in terms of therapeutic innovation.
