An Assessment of Clinical Development Time for Novel Oncology Drugs Approved by the U.S. Food & Drug Administration

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Publication Date

8-8-2025

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Presentation: 51:16

Abstract

Timely availability of novel cancer therapies is essential for patients, especially those who have exhausted standard treatment options. This study evaluated the clinical development time for novel oncology drugs approved by the U.S. FDA from 2000 to 2024. The impact of the Accelerated Approval pathway on clinical development time and conversion time from Accelerated Approval to full approval was also assessed. Kaplan-Meier curves and Cox proportional hazards models were used to estimate clinical development time.

Among 223 drugs included in the analysis, 87 were approved for hematologic malignancies and 136 were approved for solid tumors. The FDA’s expedited programs were frequently utilized: 39% received Breakthrough Therapy Designation, 41% received Fast Track Designation, 75% underwent Priority Review, 57% received Orphan Drug Designation, and 41% received Accelerated Approval. Overall, the median time from the start of clinical development to approval was 7 years. Drugs approved via Accelerated Approval had a statistically significantly shorter median development time (6.0 years) compared to regular approval (7.9 years) (p < 0.001). Although not statistically significant, drugs with Breakthrough Therapy Designation and small molecules showed non-significant trends toward faster development (HRs > 1). Of the 92 drugs granted Accelerated Approval, 52% were converted to full approval, with a median conversion time of approximately 4.4 years.

These findings highlight the meaningful impact of FDA expedited programs in reducing development time, particularly for serious and life-threatening conditions. Frequent FDA-sponsor engagement and investment in science continue to represent opportunities to accelerate access to novel therapies.

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English

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