[REVISION HISTORY]

Daraxonrasib development for pancreatic cancer

Updated 5 times since CLSTR started tracking revisions of this situation.

What changed

2026-10-24 18:17 UTC → 2026-10-24 19:31 UTC · added ~~removed~~

In September 2026, Felice Antonio Spaccavento, a health official in the Puglia region of Italy, formally requested that the Italian Medicines Agency (AIFA) accelerate access to the targeted therapy daraxonrasib. The request was prompted by an appeal from a patient in Bitonto with metastatic pancreatic adenocarcinoma and aimed to activate a compassionate use program to ensure regional patients could access the drug. By October 2026, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use recommended the approval of Rasonque, which contains daraxonrasib, for treating adults with metastatic pancreatic adenocarcinoma who have failed at least one systemic therapy. This recommendation followed the Phase 3 RASolute 302 study, which indicated that daraxonrasib achieved a median overall survival of 13.2 months compared to 6.7 months for standard chemotherapy. The study also reported a 60 percent reduction in the risk of death and a lower treatment discontinuation rate due to adverse events compared to chemotherapy. While the final decision regarding European market authorization rests with the European Commission, the drug received approval from the U.S. Food and Drug Administration (FDA) on August 26, 2026. In Greece, patient requests for access to the treatment have already been approved while the formal European regulatory process is being finalized. At the 2026 European Society for Medical Oncology (ESMO) Congress in Madrid, further details from the RASolute 302 trial indicated that the survival benefit remains consistent across various patient profiles, including different RAS genotype subgroups—such as G12D, G12V, and G12R—and even among patients without an identified RAS mutation. The congress also highlighted broader challenges regarding drug accessibility in Europe, noting that only 51 percent of new drugs approved by the EMA are made available on average, with an average wait time of 655 days.

Versions

Only revisions since CLSTR began indexing content versions appear here. Select a version to see what changed compared to the one before it.