- FDA Announcements
FDA Approved for RRMM: Xpovio (selinexor) tablets + Dexamethasone
Updated: Oct 16, 2021
On July 3, 2019, the Food and Drug Administration granted accelerated approval to selinexor (XPOVIO, Karyopharm Therapeutics) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma (RRMM) 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.
Efficacy was evaluated in 122 patients enrolled in Part 2 of STORM (KCP-330-012; NCT02336815), a multicenter, single-arm, open-label study of patients with RRMM who had previously received three or more anti-myeloma treatment regimens including an alkylating agent, glucocorticoids, bortezomib, carfilzomib, lenalidomide, pomalidomide, and an anti-CD38 monoclonal antibody. In addition, the disease was refractory to glucocorticoids, a proteasome inhibitor, an immunomodulatory agent, an anti-CD38 monoclonal antibody, and to the last line of therapy. These patients were treated with selinexor (80 mg) in combination with dexamethasone (20 mg) on days 1 and 3 of every week.
Learn more: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-selinexor-multiple-myeloma
07/03/2019: FDA Approval