FDA Grants Breakthrough Therapy Designation to First-Line Daraxonrasib Plus Chemo in mPDAC

The FDA granted breakthrough therapy designation to daraxonrasib combined with gemcitabine and nab-paclitaxel for first-line treatment in metastatic pancreatic ductal adenocarcinoma (mPDAC), based on promising efficacy and safety data from a phase 1/2 trial in RAS-mutant patients.

This Wire brief sits within Fusion42's coverage of Biotech, and 49 sources have reported it between 26 Aug 2026 and 15 Sep 2026.