PFS-driven accelerated approvals fail to guarantee durable overall survival benefits.
Confirming long-term overall survival and durability remains a major hurdle for oncology therapies that initially secure accelerated approval based on early progression-free survival metrics.
The same conclusion keeps arriving from across the workspace's research — 1 topics independently instantiate this theme. Filter the evidence by where it came from:
Long-term follow-up of a drug approved via accelerated pathways revealed a significant degradation in its progression-free survival benefits over time.
An oncology drug that previously secured accelerated approval based on early metrics failed its confirmatory overall survival trial.
A confirmatory trial met its surrogate PFS endpoint but failed to show overall survival due to a worrying spike in patient deaths.