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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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Paul Goldberg
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