Xpovio FDA Approval History
FDA Approved: Yes (First approved July 3, 2019)
Brand name: Xpovio
Generic name: selinexor
Dosage form: Tablets
Company: Karyopharm Therapeutics Inc.
Treatment for: Multiple Myeloma; Diffuse Large B-cell Lymphoma
Xpovio (selinexor) is a first in class Selective Inhibitor of Nuclear Export (SINE) XPO1 antagonist for the treatment of patients adult patients with multiple myeloma (RRMM) and relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
- Multiple Myeloma
- 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.
- Diffuse Large B-Cell Lymphoma
- For the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy.
These indications are approved under accelerated approval based on response rate. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.
Development Timeline for Xpovio
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