Skip to content

FDA approves daraxonrasib for advanced pancreatic cancer

scienceAug 26, 202629624

The Food and Drug Administration approved daraxonrasib, a once-daily pill from Revolution Medicines sold as Rasonque, to treat advanced pancreatic cancer. The agency granted expedited approval more than six months ahead of its target date after a randomized, company-funded trial of 500 patients whose metastatic disease had stopped responding to prior treatment. Patients receiving daraxonrasib lived a median 13.2 months versus 6.7 months for those given chemotherapy, and experienced fewer severe side effects; reported adverse effects included skin rash, mouth sores, diarrhea and other digestive issues. Daraxonrasib blocks mutated proteins in the RAS gene family, including KRAS mutations that drive more than 90 percent of pancreatic cancers, an approach long considered undruggable. The drug drew public attention earlier this year when former Senator Ben Sasse described symptom improvement on television, prompting the FDA to allow expanded access before formal approval. Experts said the approval is a significant improvement and could open doors for other companies developing RAS-targeting cancer therapies, the FDA acting commissioner Kyle Diamantas said the agency must deliver cures and meaningful treatments as quickly as possible.

3 sources