The accelerated approval pathway, reformed
New rules demand confirmatory trials be underway before approval.
Background
Researchers reported the results at a major congress this year1. The findings add to a growing body of evidence.
Study design
The randomised, double-blind trial enrolled patients across 20 countries.
| Arm | Patients | 5-yr survival |
|---|---|---|
| Combination | 314 | 52% |
| Monotherapy | 316 | 44% |
"These are the numbers we hoped to see, but they come at a cost."
What it means for patients
Experts caution that longer follow-up is needed.
- ClinicalTrials.gov registry entry. ↩
Sources
- ClinicalTrials.gov. U.S. National Library of Medicine, 2026-01-01
Medical disclaimer: For information only, not medical advice. Speak to a qualified healthcare professional about your care.
About the author
MSc Molecular Biology
Clara covers oncology and drug development. She previously reported on biotech for a decade.
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