FDA Grants Breakthrough Approval to New Pancreatic Cancer Pill That Doubles Survival

The U.S. Food and Drug Administration approved daraxonrasib, sold under the brand name Rasonque, a daily pill that could nearly double the overall survival time for patients with pancreatic cancer.

A late‑stage clinical trial involving 500 patients found that those taking the drug lived an average of 13.2 months versus 6.6 months in a control group on standard chemotherapy. This represents an almost two‑fold gain in survival.

Daraxonrasib works by locking onto and shutting off the mutated KRAS gene, a driver mutation found in over 90% of pancreatic tumors. The drug was given a “Breakthrough Therapy” designation in 2025 and was approved six months ahead of schedule because it demonstrated unprecedented results in a disease with a high unmet need.

Side‑effect rates were lower than chemotherapy: rash, diarrhoea, nausea, fatigue and vomiting occurred in 44% of patients on the drug compared with 57.5% of those receiving chemotherapy.

The drug’s performance has already brought hope to patients, including former U.S. Senator Ben Sasse, who reported tumor shrinkage in his own clinical trial after being diagnosed with stage‑4 pancreatic cancer.

Source: BBC News, 6 minutes ago (BBC)