The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 8 to 5 against accelerated approval of a new drug application (NDA) for selinexor for the treatment of patients with penta-refractory multiple myeloma, recommending delaying a decision on the drug until results are available from the pivotal phase III BOSTON trial.
It is hoped that the phase III BOSTON trial (NCT03110562) will allow the FDA to make a more informed decision on selinexor. The open-label trial is evaluating the addition of selinexor to bortezomib (Velcade) and low-dose dexamethasone versus bortezomib and low-dose dexamethasone alone in patients with relapsed/refractory multiple myeloma who have received 1 to 3 prior anti–multiple myeloma regimens.
The NDA for the accelerated approval of selinexor is being reviewed under the FDA’s priority review program. The FDA now has until April 6, 2019, to consider ODAC’s recommendation and make a final decision on whether or not to grant selinexor an accelerated approval.
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