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Drug Approvals and Real-World Use: The Case of Selinexor in Multiple Myeloma

Aaron Goodman (@AaronGoodman33), MD, hematologist…

First published

01/05/2021

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science

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Summary

Aaron Goodman (@AaronGoodman33), MD, hematologist/oncologist, University of California San Diego, and Jatin Shah (@JatinShahMD), MD, executive vice president and chief medical officer, Karyopharm Therapeutics, join the show for a deep consideration of oncology drug approvals in the context of RCTs, RWE, surrogate endpoints, and outcomes. The larger discussion is framed around Karyopharm’s STORM study of selinexor in refractory multiple myeloma and whether the FDA had enough convincing data to approve the drug. Contention ensues around the findings of Karyopharm's BOSTON study and whether they should be used to justify selinexor as a second-line treatment.

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Healthcare Unfiltered

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