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EMA’s human medicines committee (CHMP) has started a phased review of data on daraxonrasib, a medicine intended for the treatment of metastatic pancreatic cancer. A phased review aims to accelerate the assessment of a medicine by evaluating the data in phases, as they become available.
EMA’s decision to start a phased review of daraxonrasib is based on the results of a phase 3 study which compared daraxonrasib with chemotherapy in patients with metastatic pancreatic cancer who had received prior treatment.
People with metastatic pancreatic cancer whose disease progressed after previous treatment have very limited treatment options and a poor prognosis, with a life expectancy of about 6 months. There is therefore a significant unmet medical need for these patients.
Daraxonrasib has been recognised as a high priority under EMA’s Cancer Medicines Pathfinder project, based on its potential to address a high unmet medical need. Consequently, its eligibility for a centralised marketing authorisation application was expedited. With a view to accelerating the assessment, the CHMP has agreed to review data (quality, nonclinical and clinical) in a phased approach as they become available, ahead of the submission of a full marketing authorisation application.
The review of daraxonrasib will serve as an example for some of the provisions of the reformed EU pharmaceutical legislation which is expected to strengthen the use of phased reviews. This approach is foreseen as a tool to allow for a more agile, streamlined evaluation of medicines which would ultimately lead to earlier patient access to promising treatments.
Medicines assessed under phased reviews are subject to the same standards for quality, safety and efficacy as any other medicine.
The overall review timeline for daraxonrasib cannot be anticipated; however, the process is expected to be shorter than a regular evaluation since part of the assessment will be carried out before the complete marketing authorisation application is submitted.
Looking ahead, EMA, in agreement with the CHMP, will consider further medicines under development for phased review when this approach is feasible and expected to accelerate assessment. This will be decided on a case-by-case basis, based on whether the medicine is likely to address an unmet medical need and is expected to be of major interest from the point of view of public health, in particular as regards therapeutic innovation.