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2 clusters · 5 sources · 30 days · First seen · Last updated

Daraxonrasib development for pancreatic cancer

Overview

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.

Entities

European Medicines Agency · Felice Antonio Spaccavento · AIFA · Puglia · daraxonrasib

Claims

What the coverage asserts, and how many sources carry each claim.

Timeline

  1. [HEALTH] 3 sources
    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.

  2. [HEALTH] 2 sources
    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.

Sources

ad-hoc-news.de · bitontoviva.it · dabitonto.com · das-wissen.de · deutschesgesundheitsportal.de

This summary has been updated 5 times: see revision history