Nexpovio (selinexor)
- Region
- 🇪🇺 EU
- Active substance
- selinexor
- Company
- Stemline Therapeutics B.V.
- Status
- Authorised
- Therapeutic area
- Multiple Myeloma
- CHMP opinion
- Thu 28 Jan 2021
- EU approval
- Fri 26 Mar 2021
- Designations
- Additional monitoring
- Application
- EMEA/H/C/005127
- ATC
- L01XX66
- Official record
- www.ema.europa.eu
Indication
NEXPOVIO 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 multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.
Regulatory milestones
No milestones recorded in the last year.
Follow Nexpovio
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.