Health
FDA Debates Fate of a $900,000 Cancer Drug That May Not Work
- Folotyn was cleared in 2009 but efficacy trial is years late
- FDA hearing Thursday to review delayed lymphoma drug studies
This article is for subscribers only.
The cancer drug Folotyn, one of the most expensive in the US, received a short-cut approval from US regulators to treat a rare form of lymphoma 14 years ago, but officials still don’t have conclusive evidence it works.
Companies cleared to sell drugs through an “accelerated approval” pathway are supposed to promptly conduct follow-up studies to confirm their medicine is effective. But former and current owners of Folotyn, now an Acrotech Biopharma drug, have pushed back the deadline to complete that work at least 10 times, according to a summary of their correspondence with regulators. Acrotech doesn’t expect to complete its study until 2030.