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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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Potency Assay Issues Delayed US FDA Approval Of Mesoblast’s Ryoncil For Years

 
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Lilly Wins EU Thumbs Up For Kisunla After EMA Reverses Rejection

 
• By Neena Brizmohun

The European Medicines Agency says that Eli Lilly's Alzheimer's disease drug should be approved for use in the EU, now that it has re-examined the negative opinion it previously adopted.

EMA Says ‘No’ To Roche/Sarepta’s Elevidys, US FDA Investigates Fourth Death

 
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• By Sue Sutter

The FDA will take a hard line on trial design and site selection to ensure applicability to the US, Oncology Center of Excellence Director Richard Pazdur said during a meeting on GSK's Blenrep.