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Selinexor FDA Submission Started for Multiple Myeloma

Jason M. Broderick @jasoncology
Published: Wednesday, Jul 18, 2018

A rolling submission of an FDA new drug application (NDA) has been submitted for selinexor for the treatment of patients with penta-refractory multiple myeloma, according to Karyopharm Therapeutics, the manufacturer of the XPO1 inhibitor.

In the quad-refractory group, the median age was 62 years (range, 41-78), the median number of prior regimens was 7 (range, 3-16), and the median duration from diagnosis was 4 years (range, 1-6). Eighty-three percent of patients received the 6-dose regimen and 17% of patients received the 8-dose regimen.

Among the penta-refractory cohort, the median age was 68 years (range, 34-78), the median number of prior regimens was 7 (range, 5-17), and the median duration from diagnosis was 4 years (range, <1-35). Thirty-five percent of patients received the 6-dose regimen and 65% of patients received the 8-dose regimen.
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