Nexpovio(selinexor)
Oncology· 1457 cited findings· 2 source documents
Company: Stemline B V
What the regulatory reviews say
Nexpovio (selinexor) 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. The marketing authorisation application was submitted on 9 January 2019, and a Conditional Marketing Authorisation was granted following a CHMP positive opinion on 28 January 2021.
In a Phase 3 trial enrolling 402 patients, the Overall Response Rate (ORR) for Nexpovio was 25.3%. The median Overall Survival (OS) was 8.4 months. Notable safety findings include a discontinuation rate due to adverse events of 29.2% and a discontinuation rate due to progression of 55.7%. Vomiting was reported in 42.5% of patients in the selinexor-dexamethasone (Sd) group, and 100% of patients in this group experienced at least one treatment-emergent adverse event.
Nexpovio received orphan medicinal product designation on 19 November 2014, which was subsequently withdrawn on 25 February 2021.
Key figures — cited to the source page
| Overall response rate (ORR) | 25.3 | Stemline B V — Nexpovio EMA EPAR public assessment report (E, p.14 |
| median Duration of Response | 180 | Stemline B V — Nexpovio EMA EPAR public assessment report (E, p.52 |
| OS (median) | 8.4 | Stemline B V — Nexpovio EMA EPAR public assessment report (E, p.89 |
| Discontinuation rate due to AE | 29.2 | Stemline B V — Nexpovio EMA EPAR public assessment report (E, p.89 |
| Discontinuation rate due to progression | 55.7 | Stemline B V — Nexpovio EMA EPAR public assessment report (E, p.89 |
| Vomiting (Sd group) | 42.5 | Stemline B V — Nexpovio EMA EPAR public assessment report (E, p.103 |
| Patients with at least 1 TEAE (Sd group) | 100 | Stemline B V — Nexpovio EMA EPAR public assessment report (E, p.103 |
| CHMP positive opinion date | 28 January 2021 | Stemline B V — Nexpovio EMA EPAR public assessment report (E, p.11 |
Source documents
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.