Treats multiple myeloma. NDA 212306, held by Karyopharm Theraps. Selinexor.
As of Nov 14, 2026, NDA 212306 (Xpovio), held by Karyopharm Theraps, was first approved by FDA on Jul 3, 2019, with 7 approved supplements and 0 published complete response letters.
XPOVIO is a nuclear export inhibitor indicated: In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody. 1.
| Apr 23, 2026 | Supplement 18Efficacy (new indication or use) · Standard review | Approved | |
| Dec 18, 2020 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Jun 22, 2020 | Supplement 1Efficacy (new indication or use) · Priority review | Approved | |
| Jul 3, 2019 | Original applicationNew molecular entity · Priority review | Approved |
| Apr 23, 2026 | Supplement 18Efficacy (new indication or use) · Standard review | Approved | |
| Sep 26, 2025 | Supplement 16Labeling · Standard review | Approved | |
| Mar 10, 2025 | Supplement 13Manufacturing | Approved | |
| Jul 15, 2022 | Supplement 11Labeling · Standard review | Approved | |
| Mar 28, 2022 | Supplement 10Labeling · Standard review | Approved | |
| Dec 18, 2020 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Jun 22, 2020 | Supplement 1Efficacy (new indication or use) · Priority review | Approved | |
| Jul 3, 2019 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
