JCO Oncol Pract. 2026 Apr 1:OP2501270. doi: 10.1200/OP-25-01270. Online ahead of print.
ABSTRACT
PURPOSE: The objective of priority review is to expedite the review duration for drugs that provide significant improvements. We analyzed the duration of regulatory review of cancer drugs granted priority versus nonpriority review and differences in the proportion of cancer drugs with high therapeutic value granted priority versus nonpriority review in the United States, European Union, and Switzerland.
METHODS: In this cross-sectional study, we used US Food and Drug Administration’s (FDA), European Medicines Agency’s (EMA), and Swissmedic’s databases to identify all new cancer drugs approved in 2010-2024, their submission and approval dates, and approval pathways. European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) and ESMO-Magnitude of Clinical Benefit Scale for Haematological Malignancies scores were calculated to assess their therapeutic value. We applied summary statistics (medians and IQR) to describe differences in review duration for priority versus nonpriority review. Review duration was calculated from submission to approval date. For estimated differences in proportions of high therapeutic value scores for drugs granted priority versus nonpriority review, we calculated classical normal 95% CIs.
RESULTS: In all, 144 (86%) of 168 cancer drugs were granted priority review by the FDA, 37 (25%) of 147 by EMA, and 37 (28%) of 132 by Swissmedic. Of those, the FDA reviewed 30%, EMA 5%, and Swissmedic 49% within the required time period; review duration was similar for drugs with high and low therapeutic value. The difference in the proportion of high value scores between priority and nonpriority review was -4% (95% CI, -20 to 13) for the FDA, 22% (95% CI, 6 to 38) for EMA, and 17% (95% CI, <1 to 33]) for Swissmedic.
CONCLUSION: It could be beneficial for patients if agencies applied more scrutiny in the selection of which cancer drugs to grant priority review. Such drugs should have a high therapeutic value, and their review should be completed in a timely manner to enable quicker access to important cancer drugs for patients. Although the FDA would need to take the most substantial steps, EMA and Swissmedic could also improve their systems.
PMID:41921119 | DOI:10.1200/OP-25-01270
