Overview
- The FDA said Friday it will let some patients with previously treated metastatic pancreatic ductal adenocarcinoma receive daraxonrasib before full approval.
- Regulators cleared an expanded‑access treatment protocol that must be requested by a patient’s licensed treating physician, since patients and caregivers cannot apply directly.
- Company-reported results from a late-stage trial showed median survival of 13.2 months on daraxonrasib versus 6.7 months on standard chemotherapy, and the pill is taken three times a day and blocks a growth signal in cancer cells.
- Revolution Medicines says it is preparing to open the U.S. program quickly with a focus on safe, fair access, and the drug also holds a priority review voucher intended to speed FDA evaluation.
- The pill is also being studied in other late-stage settings, including non‑small cell lung cancer, as NCI data underscore the disease’s toll with more than 52,000 U.S. pancreatic cancer deaths expected in 2026.