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.
The confirmatory trial failed to establish overall survival benefit, illustrating that early clinical progression metrics do not always translate into durable survival.
With its PFS endpoint missed, the program survives only if the overall-survival readout lands — the same primacy of durable OS over early PFS metrics that haunts accelerated approvals.
Zynlonta's confirmatory trial successfully hit its progression-free survival target but failed to establish any durable overall survival benefit due to a dramatic imbalance in patient deaths.
Market access granted on progression-free benefit even though final overall survival showed no significant advantage extends the PFS-without-OS pattern.