ReviewClinical and translational science2026
Understanding Postmarketing Requirements and Commitments for CYP3A-Mediated Drug-Drug Interactions: An Analysis of FDA-Approved Drugs From 2015 to 2024.
Review in Clinical and translational science, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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5 authors.
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Abstract
Addressing knowledge gaps at drug approval through drug-drug interaction (DDI)-related postmarketing requirements (PMRs) and commitments (PMCs) is essential for safe and effective use. This analysis reviewed CYP3A-related PMRs and PMCs, the most evaluated enzyme in postmarketing studies, to characterize their scope. CYP3A-related PMRs, PMCs, and labeling recommendations were identified for small-molecule new molecular entities approved by the U.S. Food and Drug Administration (2015-2024) using the Certara Drug Interaction Database (DIDB). The latest product labels from Drugs@FDA were reviewed for updates. Drugs were categorized as CYP3A substrates, inhibitors, or inducers based on PMR/PMC language. Of 332 approved drugs, 51 (15%) had CYP3A-related PMRs/PMCs, totaling 91 studies (53 PMRs, 37 PMCs, and 1 unspecified). About two-thirds were oncology drugs, including 25 kinase inhibitors. As substrates, 37 drugs had 65 requests: 26 with inhibitors (all PMRs) and 39 with inducers (30 PMCs, 8 PMRs, and 1 unspecified); 20 included physiologically based pharmacokinetic (PBPK) modeling. As precipitants, 25 drugs had 26 requests: 12 as inhibitors (11 PMRs, 1 PMC), 14 as inducers (8 PMRs, 6 PMCs), with only 1 PBPK option. Requests most often involved studies with a CYP3A substrate (N = 24), moderate inducer (N = 21), strong inducer (N = 15), strong inhibitor (N = 10), and moderate inhibitor (N = 9). Initial labeling recommendations were issued for 60 studies (65%; 35 drugs), and 53 studies (58%; 29 drugs) resulted in label updates. Overall, CYP3A-mediated DDIs remain a key focus of postmarketing evaluation, particularly for oncology drugs. PMRs and PMCs are critical for resolving uncertainties and informing label updates.
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