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Elzonris: A Case Study In Divergent Regulatory Decisions

 
• By Ian Schofield

Stemline Therapeutics’ Elzonris was approved for a rare cancer in Europe in January, following a long and arduous two-year journey through the EU regulatory process that included an initial rejection and a subsequent re-examination by the EMA. Its fortunes were very different in the US, where the review took just six months from filing to approval.

Drug Review Profile: Elzonris
• Source: Alamy

It’s not unusual for drug regulators from different countries to take quite different stances on whether a new medicine should be approved for marketing. Stemline Therapeutics, Inc.’s orphan medicine Elzonris (tagraxofusp), whose EU authorization in January came two years after its approval in the US, is a striking example of just how far agencies’ views can diverge.

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