FDA accelerated approvals under pressure

By Dr Nicola Davies

The accelerated approval pathway has long represented one of the US Food and Drug Administration’s (FDA) most important tools for speeding access to promising therapies.

The system allows drugs for serious or life-threatening diseases to reach patients earlier by relying on surrogate or intermediate clinical endpoints that are reasonably likely to predict real clinical benefit. These endpoints may include tumor response rates, progression-free survival, or biomarker shifts that serve as early signals of potential long-term advantage.