FDA approves new pancreatic cancer pill that doubles survival in trial
The FDA has approved daraxonrasib, a twice-daily pill for metastatic pancreatic cancer patients who have already undergone chemotherapy. In a phase 3 trial, the drug extended median overall survival to 13.2 months compared with 6.6 months for chemotherapy. The approval marks a significant advance for a cancer with a five-year survival rate of about 13 percent.
The phase 3 trial enrolled 500 patients with metastatic disease who had already received chemotherapy. Among participants carrying specific cancer-driving gene mutations, the drug doubled median survival compared to chemotherapy, and similar benefits appeared across the full participant group. Some treated patients survived for years, a rare outcome for late-stage pancreatic cancer.
Pancreatic cancer carries the lowest five-year survival rate of any major cancer, roughly 13 percent, largely because tumors frequently stop responding to chemotherapy or resume growth during treatment. The manufacturer has not disclosed pricing, and approval applies specifically to patients who have exhausted chemotherapy options.
This approval could meaningfully shift expectations for a cancer historically viewed as nearly untreatable in late stages. Patients who have exhausted chemotherapy may gain additional months or years of life, potentially altering how oncologists sequence treatments and discuss prognosis. However, the drug's undisclosed cost may affect access and insurance coverage, and the broader impact could extend to research priorities, as this success may encourage further investigation into targeted therapies for other difficult-to-treat cancers.