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Xpovio Avoided Complete Response Letter Through Late-Cycle Submission Of BOSTON Data

 
• By Michael Cipriano

After US FDA's Oncologic Drugs Advisory Committee voted to delay approval of Karyopharm's multiple myeloma drug Xpovio, the company submitted some data from the Phase III BOSTON trial, which prompted the FDA to award an accelerated approval for a narrower indication.

Drug Review Profile regular column

Karyopharm Therapeutics Inc.'s submission of Phase III data near the end of the review cycle for the company's multiple myeloma treatment Xpovio (selinexor) helped to save the drug from a complete response letter and ultimately score an accelerated approval following a three-month user fee date extension, a US Food and Drug Administration review document shows.

The FDA granted Xpovio, a nuclear export inhibitor, accelerated approval on 3 July 2019 in combination with dexamethasone for the...

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