XPOVIO (Antengene (Aus) Pty Ltd)
Product name
XPOVIO
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
242 (255 working days)
Active ingredients
selinexor
Registration type
NCE/NBE
Indication
Xpovio (film-coated tablet) is 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 orrefractory multiple myeloma (RRMM) who have received at least three prior therapies and whose disease is refractory to at least one proteasome inhibitor, at least one immunomodulatory medicinal product (IMiD), and an anti-CD38 monoclonal antibody (mAb).