The cancer drug Pepaxto got its blessing from US regulators in 2021 based on a single study. The trial had found the intravenous treatment shrank tumors in almost a quarter of 97 bone marrow cancer patients for whom nothing else worked. Despite the small sample, the US Food and Drug Administration gave Pepaxto the greenlight using an accelerated approval process meant for getting promising medicines to people with few or no other options.

Now, the FDA is testing the power of a new law to try to rescind the drug’s approval. A follow-up study has since sowed doubt on Pepaxto’s efficacy and even suggested it might be dangerous. Although a finding such as that might sound like the death knell for any drug, the agency has struggled to efficiently take fast-tracked, not fully proven treatments off the market.

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FDA Tests New Power to Pull Some Fast-Tracked Drugs Off Market