Nexpovio
Authorised
This medicine is authorised for use in the European Union
selinexor
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Nexpovio is a cancer medicine used to treat multiple myeloma (a cancer of the bone marrow). It is used together with two other medicines, bortezomib and dexamethasone, in adults who have received at least one previous treatment. It is also used together with dexamethasone in adults who have received at least four previous treatments and whose disease has worsened since the last treatment.
Nexpovio contains the active substance selinexor.
Nexpovio can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in the treatment of multiple myeloma.
Nexpovio is available as tablets to be taken by mouth once a week when used in combination with bortezomib and dexamethasone or twice a week when used with only dexamethasone. The dose depends on the treatment combination used. Treatment can continue for as long as the patient benefits from it. Treatment may be stopped or the dose reduced if the patient has severe side effects or the disease gets worse.
For more information about using Nexpovio, see the package leaflet or contact your doctor or pharmacist.
The active substance in Nexpovio, selinexor, blocks the action of a protein called exportin 1 (XPO1). XPO1 is found at high levels in many cancer cells, where it prevents the action of certain proteins that help stop cancer growth. By blocking XPO1, the medicine enhances the action of these proteins, causing the death of the cancer cells and thereby slowing progression of the disease.
A main study in 402 patients with multiple myeloma who had received at least one previous treatment found that Nexpovio given together with bortezomib and low-dose dexamethasone increased the time that patients lived without their disease getting worse. Patients receiving this combination lived for an average of 13.9 months without their disease getting worse, compared with 9.5 months for those who received a combination of only bortezomib and low-dose dexamethasone.
A second main study involving 83 patients with multiple myeloma showed that Nexpovio given together with low-dose dexamethasone was effective at reducing the cancer in patients whose disease had not improved after four previous treatments and had worsened after the last one. A quarter of patients (25.3%) had a reduction of their cancer with Nexpovio that lasted on average for 4 months.
The most common side effects with Nexpovio used together with bortezomib and dexamethasone (which may affect more than 3 in 10 people) are thrombocytopenia (low blood platelet counts), nausea (feeling sick), tiredness, anaemia (low red blood cell counts), decreased appetite, diarrhoea and peripheral neuropathy (nerve damage in the arms and legs).
The most common serious side effects with Nexpovio used together with bortezomib and dexamethasone (which may affect up to 2 in 10 people) are pneumonia (lung infection), cataract, sepsis (blood poisoning), diarrhoea, vomiting and anaemia.
The most common side effects with Nexpovio used together with dexamethasone (which may affect more than 3 in 10 people) are nausea, vomiting, decreased appetite, weight loss, diarrhoea, tiredness, thrombocytopenia, anaemia, low levels of white blood cells and hyponatraemia (low blood sodium levels).
The most common serious side effects with Nexpovio used together with dexamethasone (which may affect up to 1 in 10 people) are pneumonia, sepsis, thrombocytopenia, anaemia and damage to the kidneys.
For the full list of side effects and restrictions of Nexpovio, see the package leaflet.
Nexpovio used in combination with other cancer medicines has shown benefits in patients with multiple myeloma, both in those who have received at least four previous treatments and whose disease has come back, and in those who have received at least one previous treatment. In terms of safety, although Nexpovio has important side effects, they are generally considered manageable. The Agency therefore decided that Nexpovio’s benefits are greater than its risks and it can be authorised for use in the EU.
Nexpovio was originally given ‘conditional authorisation’ because there was more evidence to come about the medicine. As the company has supplied the additional information necessary, the authorisation has been switched from conditional to full authorisation.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Nexpovio have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Nexpovio are continuously monitored. Side effects reported with Nexpovio are carefully evaluated and any necessary action taken to protect patients.
Nexpovio received a conditional marketing authorisation valid throughout the EU on 26 March 2021. This was switched to a full marketing authorisation on 18 July 2022.
Product information
Latest procedure affecting product information:
N/0016
14/08/2023
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Nexpovio
- Active substance
- Selinexor
- International non-proprietary name (INN) or common name
- selinexor
- Therapeutic area (MeSH)
- Multiple Myeloma
- Anatomical therapeutic chemical (ATC) code
- L01XX66
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic 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.
News on Nexpovio
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