Xpovio
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
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
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.
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).
- 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.