selinexor

FDA Drug Profile — XPOVIO

selinexor is listed in the FDA National Drug Code directory with 8 NDC codes, marketed under brand name including XPOVIO. Available dosage form: tablet, film coated.

Drug Details

Generic Name
selinexor
Brand Names
XPOVIO
Application Number
NDA212306
Sponsor
Karyopharm Therapeutics Inc.
NDC Codes
8
Dosage Forms
TABLET, FILM COATED
Routes
ORAL
Active Ingredients
SELINEXOR

Indications and Usage

1 INDICATIONS AND USAGE 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 ( 1.1 ). 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 ( 1.1 ). 1.1 Multiple Myeloma XPOVIO in combination with bortezomib and dexamethasone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. XPOVIO in combination with dexamethasone is indicated 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.