# Daraxonrasib development for pancreatic cancer > Live situation record from CLSTR: https://clstr.news/situations/daraxonrasib-development-for-pancreatic-cancer > Updated: 2026-10-18T09:03:05.000Z. Sources: 5. Developments: 2. 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. ## Claims - Daraxonrasib increased median overall survival to 13.2 months in patients with metastatic pancreatic cancer. (corroborated by 7 sources) - Standard chemotherapy resulted in a median survival of approximately 6.6 to 6.7 months in the study comparison group. (corroborated by 7 sources) - The survival benefit of daraxonrasib was observed across all RAS genotype subgroups. (corroborated by 6 sources) - Daraxonrasib is an oral targeted therapy designed to block multiple forms of the active RAS protein. (corroborated by 6 sources) - The INTerpath-001 trial showed an mRNA vaccine plus pembrolizumab reduced melanoma recurrence or death risk by 42%. (corroborated by 6 sources) - The FDA approved daraxonrasib on August 26, 2026. (corroborated by 5 sources) - Dostarlimab achieved a 71% complete clinical response in patients with locally advanced dMmr/Msi-H rectal cancer. (corroborated by 5 sources) - The 12-month maintenance rate of complete clinical response in the Azur-1 study was 68%. (corroborated by 5 sources) - Divarasib reduced the risk of death by 44% in patients with Kras G12C mutation non-small cell lung cancer. (corroborated by 5 sources) - Sacituzumab govitecan showed benefits in progression-free survival for advanced triple-negative breast cancer patients in the Ascent studies. (corroborated by 5 sources) - The Natalee study shows that ribociclib combined with hormone therapy reduces the risk of breast cancer recurrence. (corroborated by 4 sources) - Ribociclib may also decrease the risk of death from breast cancer. (corroborated by 4 sources) ## Timeline ### 2026-10-18: EMA recommends Daraxonrasib for advanced pancreatic cancer treatment The EMA has recommended Daraxonrasib for treating metastatic pancreatic cancer, showing a significant increase in median overall survival compared to standard chemotherapy in Phase 3 trials. 3 sources. https://clstr.news/cluster/ema-recommends-daraxonrasib-for-advanced-pancreatic-cancer-treatment ### 2026-09-18: Puglia health official urges AIFA to accelerate access to daraxonrasib Puglia health official Felice Antonio Spaccavento has urged AIFA to accelerate compassionate use access to the drug daraxonrasib for a patient in Bitonto with metastatic pancreatic cancer. 2 sources. https://clstr.news/cluster/puglia-health-official-urges-aifa-to-accelerate-access-to-daraxonrasib --- Cite as: Daraxonrasib development for pancreatic cancer. CLSTR, https://clstr.news/situations/daraxonrasib-development-for-pancreatic-cancer