FDA approves landmark pancreatic cancer drug that’s shown to improve survival

The U.S. Food and Drug Administration has officially approved an innovative new medication aimed at treating pancreatic cancer, the deadliest form of cancer with a low five-year survival rate of 13%. The drug, named daraxonib and sold under the name Rasonque, is the first of its kind and was granted expedited approval by FDA officials.

Daraxonib targets a mutated protein responsible for fueling tumor growth in over 90% of pancreatic cancer cases, a feat previously unattainable. The daily pill, manufactured by Revolution Medicines, was proven in a clinical trial to more than double patients' survival time compared to standard chemotherapy. In the study, 500 patients with metastatic pancreatic cancer were randomly assigned to receive either the experimental treatment or additional chemotherapy.

Those taking daraxonib lived an average of 13.2 months, while chemotherapy recipients survived for a median of 6.7 months.

Pancreatic cancer is notoriously difficult to detect before it spreads to other organs, accounting for around 67,000 new cases and 52,000 deaths in the United States annually. The drug's approval came months ahead of schedule, and public interest was notably high following former Senator Ben Sasse's discussion of its pain-reducing effects on CBS' "60 Minutes." Expanded access was granted to select patients who met specific criteria before the drug's official approval.