Daraxonrasib Goes to Patients Early Through Expanded Access Ahead of FDA Decision
Following dramatic RASolute 302 results, physicians nationwide are offering the oral RAS inhibitor daraxonrasib to patients under expanded-access programs before FDA approval. The drug nearly doubled median overall survival in previously treated metastatic pancreatic cancer (6.7 to 13.2 months) and Revolution Medicines has filed for FDA approval. More than 2,000 patients are on EAP, with sites across the U.S.; institutions cover IRB and safety monitoring costs. Huntsman Cancer Institute reported about 50 patients through its EAP; setup takes 2–3 weeks and delivery occurs in about 7–10 days after consent. Side effects include skin toxicity, managed with dermatology input and topical/doxycycline. Trials continue in first-line metastatic pancreatic cancer, post-surgery settings, and second-line RAS-mutant NSCLC.
