FDA Clears Daraxonrasib, First RAS-Targeting Drug for Pancreatic Cancer
The FDA has approved Rasonque (daraxonrasib), a once-daily pill designed to block multiple mutated forms of the RAS protein that drive most pancreatic adenocarcinoma tumors. It is cleared for adults with metastatic disease who have already tried one systemic treatment or cannot tolerate combination chemotherapy, and the agency says it acted ahead of its original review timeline.
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Pancreatic adenocarcinoma makes up the vast majority of pancreatic cancer cases and remains one of the deadliest tumor types due to late diagnosis and few effective drugs, so a targeted therapy addressing its core genetic driver marks a rare scientific advance. Because RAS mutations also appear in many other cancers, this approval could open the door to similar targeted approaches beyond pancreatic disease.
- Rasonque is the first approved therapy specifically targeting RAS mutations in pancreatic adenocarcinoma.
- It's intended for patients with metastatic disease who've had prior treatment or can't undergo standard multiagent chemo.
- The approval came from a 500-patient trial and was granted faster than the FDA's typical review schedule.
Source: fda.gov, 2026-08-26
Published there as: “FDA Approves First in Class Targeted Therapy for Metastatic Pancreatic Cancer”
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