Yan Leyfman: What happens when cancer drugs lose FDA approval for an indication?
Yan Leyfman, Co-founder and Executive Director of MedNews Week, shared a post on LinkedIn about a paper by Catherine Hwang et al. published in JAMA Oncology:
“What Happens When Cancer Drugs Lose FDA Approval for an Indication?
The FDA’s accelerated approval program fast-tracks treatments for serious conditions based on early evidence. But what happens when follow-up trials fail to confirm benefit – and those drugs are still on the market for other uses?
A new study looked at cancer meds like atezolizumab, idelalisib, and romidepsin that lost specific indications between 2020–2022, but remained available for other cancers. Using data from over 760,000 patients, researchers tracked how oncologists changed prescribing habits after negative confirmatory trials or FDA safety warnings.
Key insights:
- Use of these drugs decreased sharply after negative trial results – even though they were still technically available off-label
- Clinicians and/or payers appear to respond quickly to updated evidence
- Some use persisted (e.g., romidepsin) possibly due to efficacy in specific patient subtypes
However, the study also found delays of months to years between trial failures and formal FDA label withdrawals – raising concerns about patient safety and the need for faster regulatory follow-through.
Bottom line: Data matters. Timely trial results and action on approvals help protect patients from ineffective (and potentially unsafe) treatments.”
“Changes in Oncology Medication Use After Withdrawal of Accelerated Approval”
Authors: Catherine Hwang, Aaron Kesselheim, Amar Kelkar, Edward Scheffer Cliff, Benjamin Rome.
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