7 July 2026

The European Medicines Agency (EMA) announced that its Committee for Medicinal Products for Human Use (CHMP) had initiated a phased review of daraxonrasib, a medicinal product under development for the treatment of metastatic pancreatic cancer. Under this approach, quality, non-clinical, and clinical data are assessed in stages as they become available, allowing parts of the scientific evaluation to be completed before the submission of a full marketing authorisation application. The phased review is intended to accelerate the overall assessment while maintaining the same standards for quality, safety, and efficacy as the standard centralised authorisation procedure. Daraxonrasib was selected due to its potential to address a high unmet medical need and will serve as a pilot for the phased review mechanism proposed under the forthcoming EU pharmaceutical reform.

For more information, see here.