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# Karyopharm Filing NDA for Multiple Myeloma This Year
- URL: https://www.fdaweb.com/karyopharm-filing-nda-for-multiple-myeloma-this-year/
- Published: 2018-05-01T12:00:00.000Z
- Updated: 2026-09-15T00:02:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141337

Karyopharm Therapeutics says it will submit an NDA in the second half of this year for selinexor for multiple myeloma after reporting positive top-line results from the Phase 2b STORM study. Data from the study showed that selinexor achieved a 25.4% overall response rate (ORR), which included two complete responses and 29 partial or very good partial responses in patients with penta-refractory myeloma. The median duration of response, a key secondary objective, was 4.4 months, according to the company. Selinexor was recently granted a fast-track designation by FDA for the indication.

On the safety side, selinexor demonstrated a predictable and manageable tolerability profile, with safety results that were consistent with those previously reported from Part 1 of the study and from other selinexor studies, Karyopharm says. The most common adverse events were nausea, vomiting, fatigue and reduced appetite and were primarily low grade and manageable with standard supportive care or dose modification, it says.