Industry promotion of oncology drugs with accelerated approval that failed confirmatory trials Journal Article


Authors: Mooghali, M.; Ramachandran, R.; Mohammad, A.; Mitchell, A. P.
Article Title: Industry promotion of oncology drugs with accelerated approval that failed confirmatory trials
Abstract: <p>Industry payments to physician's influence prescribing, raising concern for drugs granted accelerated approval that failed confirmatory studies. We measured industry payments for oncology drugs granted accelerated approval before and after negative confirmatory study results. From 2009 to 2021, of 73 drugs granted accelerated approval, 6 (8.2%) had negative confirmatory studies and available OpenPayments data. These were withdrawn a median of 0.3 (interquartile range = 0.3-0.6) years after announcement of negative results. Two drugs had almost no payments after negative result announcement. Among other 4, average monthly payments in the year preceding announcement of negative results to the period between results and market withdrawal went from $138 to $183 for vinCRIStine sulfate, $12 317 to $4606 for Panobinostat, $152 417 to $119 066 for belantamab mafodotin, and $23 139 to $13 588 for umbralisib. Whereas payments for oncology drugs with accelerated approvals mostly decreased, industry promotion continued for certain drugs after confirmatory studies failed until drugs were withdrawn from market.</p>
Journal Title: JNCI: Journal of the National Cancer Institute
ISSN: 0027-8874
Publisher: Oxford University Press  
Publication status: Online ahead of print
Date Published: 2025-08-26
Online Publication Date: 2025-08-26
Start Page: djaf241
Language: English
ACCESSION: WOS:001574787100001
DOI: 10.1093/jnci/djaf241
PROVIDER: wos
PUBMED: 40855611
Notes: The MSK Cancer Center Support Grant (P30 CA008748) is acknowledged in the PDF -- Source: Wos
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