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

Maryam Mooghali, Reshma Ramachandran, Ayman Mohammad, Aaron P Mitchell
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Abstract

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 These were withdrawn a median of 0.3 (IQR, 0.3-0.6) years after announcement of negative results.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mostly decreased, industry promotion continued for certain drugs after confirmatory studies failed until drugs were withdrawn from market.
行业促进肿瘤药物加速审批,验证性试验失败
行业对医生的支付影响了处方,这引起了人们对加速批准的药物未能通过验证性研究的担忧。我们测量了在验证性研究结果阴性之前和之后获得加速批准的肿瘤药物的行业支付。从2009年到2021年,在73种加速批准的药物中,有6种(8.2%)具有阴性的验证性研究和可用的OpenPayments数据。这些研究在宣布阴性结果后中位数为0.3 (IQR, 0.3-0.6)年。两种药物在宣布阴性结果后几乎没有付款。在其他4种药物中,在公布阴性结果的前一年,从结果到市场退出之间的时间里,硫酸vinCRIStine的平均月支付从138美元到183美元,Panobinostat的平均月支付从12,317美元到4,606美元,belantamab mafodotin的平均月支付从152,417美元到119,066美元,umbralisib的平均月支付从23,139美元到13,588美元。虽然加速批准的肿瘤药物的支付大多减少了,但某些药物在验证性研究失败后,行业仍在继续推广,直到药物退出市场。
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