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…