Drug Safety: Sequential Surveillance Helps Regulatory Decision-Making, But Hurt By Premature Specification
US FDA and academic researchers say unknowns related to certain product aspects make it difficult to form a hypothesis in formal sequential surveillance designs.
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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.
Chronicle of the development and review of Karyopharm's Xpovio (selinexor) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies.
Karyopharm included a real-world data study to support its Xpovio NDA, but the US FDA deemed the study inadequate for an overall survival comparison to the pivotal STORM trial.