ScholarWorks@중앙대학교

초록

Most accelerated approvals for oncology drugs have been granted, few studies have characterized the regulatory outcomes of non-oncology drugs within this framework. To examine regulatory outcome and approval timelines of non-oncology drug indications, a cross-sectional analysis was performed using the Food and Drug Administration's accelerated approval database from 1992 to 2024. Among 328 accelerated approval indications, 98 (30 %) were for non-oncology drugs. Overall, 63/98 (64 %) were converted to full approval with systemic anti-infectives accounting for 50 %. Among the 77 (79 %) original indications, 55 (71 %) were converted to full approval, compared to only 8 (38 %) of the 21 supplemental indications. The median times to accelerated approval and convert to full approval for all non-oncology indications were 7.9 (IQR, 5.9–10.0) and 38.8 (IQR, 22.5–63.9) months, respectively. The median time to accelerated approval was 6.8 (IQR, 5.9–10.0) months for 90 (92 %) chemical drug indications and 8.6 (IQR, 7.9–11.0) for 8 (8 %) biologic drug indications; conversion to full approval took 38.8 (IQR, 22.8–63.8) and 42.6 (IQR, 21.3–100.6) months, respectively. Accelerated approvals for non-oncology biologic drug indications took significantly longer than those for oncology biologic indications (8.6 vs. 6.0 months; p = 0.003). These findings underscore the importance of enhanced regulatory oversight and continued post-marketing evaluation to confirm the clinical benefits of non-oncology drugs approved via the accelerated pathway.

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