Xpovio’s Solid Tumor Debut Faces Likely Three-Year Delay

 
• By Alaric DeArment
  
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Karyopharm will conduct another trial of the drug in p53 wild-type endometrial cancer after the FDA said SIENDO data were insufficient for approval.

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Karyopharm said the FDA told it during a meeting that topline trial results would not likely be sufficient for Xpovio's approval in endometrial cancer • Source: Shutterstock

Karyopharm Therapeutics had hoped to find a market for Xpovio (selinexor) in endometrial cancer based on subgroup findings from its SIENDO trial, but after conferring with the US Food and Drug Administration the firm will instead run a new clinical trial as it explores potential regulatory pathways for the drug. That means Xpovio will likely remain restricted to its current hematological cancer indications for at least the next three years.

The company said 1 March that in a meeting with the FDA, reviewers told it that topline results of the...

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