Photo Credit: gorodenkoff
The following is a summary of “Expedited pathway insights: Unveiling oncology and non-oncology drug approvals and withdrawals of USFDA and EMA,” published in the January 2025 issue of Oncology by Chaugule et al.
Health authorities undertake rigorous evaluations of comprehensive data before approving drugs, often delaying market entry. To mitigate these delays, expedited pathways have been implemented to accelerate drug availability, particularly for critical conditions. This study examines oncology and non-oncology drugs approved through various expedited pathways in the United States and Europe, utilizing data from the USFDA’s Novel Drug Approvals (2020-2023) and EMA’s Human Medicine Highlights (2020-2023).
Additionally, the study analyzes drug withdrawals and the contributing factors. The findings reveal that the accelerated approval pathway, partcularly for oncology drugs, has a higher incidence of approvals and subsequent withdrawals. These withdrawals are predominantly linked to drugs approved based on surrogate endpoints that failed to demonstrate clinical benefit in confirmatory trials. The study highlights the necessity of rigorous pre-approval evaluations and robust post-approval monitoring for drugs approved via expedited pathways, emphasizing the need for comprehensive confirmatory trials to ensure drug safety and efficacy.
Source: sciencedirect.com/science/article/abs/pii/S1040842824002828
