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Device/Product name
Active Ingredient
Date of decision
Submission type
New chemical entity
ATC codes
What was the decision based on
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Xpovio was considered favourable for the therapeutic use approved.
What steps were involved in the decision process

Registration timeline

The following table summarises the key steps and dates for this application.

Description Date
Submission dossier accepted and first round evaluation commenced 2 December 2020
First round evaluation completed 19 May 2021
Sponsor provides responses on questions raised in first round evaluation 30 June 2021
Second round evaluation completed 16 August 2021
Delegate's overall benefit-risk assessment and request for Advisory Committee advice 2 November 2021
Sponsor's pre-Advisory Committee response 17 November 2021
Advisory Committee meeting 2 and 3 December 2021
Registration decision (Outcome) 3 March 2022
Completion of administrative activities and registration on ARTG 8 March 2022
Number of working days from submission dossier acceptance to registration decision* 242

*Statutory timeframe for standard applications is 255 working days

Date of entry onto ARTG
Original publication date
Black triangle scheme
Yes. This product will remain in the scheme for 5 years, starting on the date the product is first supplied in Australia
Dose forms
Film coated tablet
20 mg
Other ingredients

Microcrystalline cellulose (PH 101 and PH 02), croscarmellose sodium, povidone, silicon dioxide, magnesium stearate, sodium lauryl sulfate, Opadry 200 optimized performance coatings 203A190001 clear and Opadry II complete film coating system 85F90892 blue

Blister pack
Pack sizes
16, 20, 24 and 32
Routes of administration

Treatment must be initiated and monitored under supervision of physicians experienced in the management of multiple myeloma.

In combination with bortezomib and dexamethasone (SVd)

The recommended starting dose of Xpovio in combination with bortezomib and dexamethasone is based on a 35-day cycle. For additional information regarding the administration of bortezomib and dexamethasone, refer to their respective prescribing information.

In combination with dexamethasone (Sd)

The recommended starting dose is 80 mg (4 x 20 mg tablets) of Xpovio on days 1 and 3 of each week.

The recommended starting dose of dexamethasone is 20 mg taken orally on days 1 and 3 of each week with Xpovio. For additional information regarding the administration of dexamethasone, refer to its Product Information.

Treatment should be continued until disease progression or unacceptable toxicity.

For further information refer to the Product Information.

Pregnancy category
DDrugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.The use of any medicine during pregnancy requires careful consideration of both risks and benefits by the treating health professional. This must not be used as the sole basis of decision making in the use of medicines during pregnancy. The TGA does not provide advice on the use of medicines in pregnancy for specific cases. More information is available from obstetric drug information services in your State or Territory.
What was approved

Xpovio (selinexor) was approved for the following therapeutic use:

Xpovio 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 or refractory 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).
What is this medicine and how does it work
Selinexor is a reversible covalent selective inhibitor of nuclear export (SINE) compound that specifically blocks exportin 1 (XPO1). XPO1 is a major nuclear export protein that transports cargo proteins and several classes of messenger ribonucleic acid (mRNA) from the nucleus to the cytoplasm. XPO1 cargoes include many tumour suppressor proteins (TSPs), growth regulator proteins (GRPs) and mRNAs of growth promoting (oncogenic) proteins. XPO1 inhibition by selinexor leads to marked accumulation of TSPs and GRPs (such as tumor protein (p)53, p21, forkhead box transcription factor class O and IkappaB kinase in the nucleus (their site of action), and reduced expression of several oncoproteins (such as c myelocytomatosis, B lymphocytes (B cell) lymphoma 2 and cyclin D1) and translation/chaperon proteins (heat shock protein 70), resulting in cell cycle arrest and apoptosis of cancer cells. The combination of selinexor and dexamethasone or bortezomib demonstrated synergistic cytostatic and cytotoxic effects in multiple myeloma in vitro and in vivo models, including those resistant to proteasome inhibitors. Selinexor demonstrated pro apoptotic activity in vitro in multiple myeloma and diffuse large B cell lymphoma cell lines, in murine xenograft models as well as in patient tumour samples.
What post-market commitments will the sponsor undertake
  • Xpovio (selinexor) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Xpovio must include the black triangle symbol and mandatory accompanying text for five years, which starts from the date that the sponsor notifies the TGA of supply of the product.
  • The Xpovio European Union (EU) risk management plan (RMP) (version 2.0, dated 7 July 2021, data lock point 18 February 2020), with Australian specific annex (version 1.2, dated 1 February 2022), included with Submission PM 2020 05458 1 6, to be revised to the satisfaction of the TGA, will be implemented in Australia.

    An obligatory component of risk management plans is routine pharmacovigilance. Routine pharmacovigilance includes the submission of periodic safety update reports(PSURs).

    Reports are to be provided in line with the current published list of EU reference dates and frequency of submission of PSURs until the period covered by such reports is not less than three years from the date of the approval letter.

    The reports are to at least meet the requirements for PSURs as described in the European Medicines Agency’s guideline on Good Pharmacovigilance Practices (GVP) Module VII-periodic safety update report (revision 1), Part VII.B structures and processes. Note that submission of a PSUR does not constitute an application to vary the registration.

  • Sponsor to submit the final clinical study report for Study XPORT MM 028 for evaluation.
  • Sponsor to submit the final clinical study report for Study KCP 330 023 for evaluation.

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