Pancreatic cancer drug fast-tracked by EU regulator

The European Medicines Agency (EMA) has begun an accelerated assessment of a potential new treatment for metastatic pancreatic cancer. Noting that pancreatic cancer is an area of high unmet need where patient outcomes are currently poor, the regulator announced that it will review data as they become available, with a view to approving it more quickly if it delivers positive safety and efficacy results.

The move follows encouraging results from a phase 3 study of daraxonrasib in patients with metastatic pancreatic cancer who had received prior treatment. Life expectancy for people with this disease is currently approximately six months.

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.

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. Medicines assessed under phased reviews are subject to the same standards for quality, safety and efficacy as any other medicine.

Looking ahead, EMA said it will consider further medicines under development for phased review 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.