ODAC gives thumbs down to single-arm trial of two-drug combination for multiple myeloma

Committee focuses on meaning of equipoise, accelerated approval, confirmatory trials

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It’s not just the absence of a randomized trial that prompted the FDA Oncologic Drugs Advisory Committee to recommend against an accelerated approval of the Karyopharm Therapeutics Inc. drug selinexor for late-stage multiple myeloma.

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I write a weekly blog for Georgetown University’s Lombardi Comprehensive Cancer Center community. Here I share an updated version of a blog post I wrote in September 2024, now supplemented by some poems I have written over the years that inspired paintings by my wife Harriet Weiner, who is a much better artist than I am a poet or writer. 
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