Industry promotion of oncology drugs with accelerated approval that failed confirmatory trials
Menée aux Etats-Unis, cette étude examine, pour les médicaments oncologiques ayant obtenu une autorisation accélérée, les financements effectués par l'industrie avant et après les résultats négatifs des études de confirmation
Industry payments to physicians 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 2009-2021, 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 These were withdrawn a median of 0.3 (IQR, 0.3-0.6) years after announcement of negative results.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 $4,606 for Panobinostat, $152,417 to $119,066 for belantamab mafodotin, and $23,139 to $13,588 for umbralisib. While 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mostly decreased, industry promotion continued for certain drugs after confirmatory studies failed until drugs were withdrawn from market.
Journal of the National Cancer Institute , résumé, 2025