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

Area of Science:

• Oncology
• Pharmaceutical Industry
• Healthcare Economics

Background:

• Accelerated approval pathways allow early drug access but require confirmatory studies.
• Industry payments to physicians can influence prescribing patterns.
• Concerns exist regarding continued promotion of drugs that fail post-market studies.

Purpose of the Study:

• To analyze industry payments for oncology drugs granted accelerated approval that subsequently failed confirmatory studies.
• To assess payment trends before and after negative confirmatory study results.

Main Methods:

• Retrospective analysis of oncology drugs granted accelerated approval between 2009-2021.
• Utilized Open Payments data to track industry payments to physicians.
• Compared payment data before and after announcement of negative confirmatory study results.

Main Results:

• Of 73 accelerated approval oncology drugs, 6 had negative confirmatory studies and available payment data.
• These drugs were withdrawn a median of 0.3 years after negative results.
• For four drugs, industry payments decreased but continued post-negative results: vinCRIStine sulfate, Panobinostat, belantamab mafodotin, and umbralisib.

Conclusions:

• Industry promotion persisted for certain oncology drugs after confirmatory studies failed.
• Physician payments continued until market withdrawal for some accelerated approval drugs.
• This highlights the need for careful monitoring of drugs on accelerated approval pathways.