FDA grants early access to daraxonrasib for pancreatic cancer patients
Updated
Updated · The New York Times · May 1
FDA grants early access to daraxonrasib for pancreatic cancer patients
8 articles · Updated · The New York Times · May 1
The programme covers previously treated metastatic pancreatic cancer patients, after Revolution Medicines sought expanded access to the unapproved three-pills-a-day drug.
No patients have received daraxonrasib outside clinical trials, where demand has exceeded limited places, and it remains unclear when eligible patients could begin treatment.
The decision follows unusually encouraging trial results in a cancer that kills more than 50,000 Americans yearly and has a five-year survival rate of about 3% after spread.
Could daraxonrasib's expanded access mark a true turning point for pancreatic cancer, or will real-world results fall short of clinical trial promises?
How might expanded access to daraxonrasib impact ongoing clinical trials, and could this affect the speed or rigor of eventual FDA approval?
Will all eligible pancreatic cancer patients have equal access to daraxonrasib, or will barriers like biomarker testing and insurance create new disparities?