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Scemblix
ARTGs
Device/Product name
Scemblix
Active Ingredient
Asciminib
Date of decision
Published
Submission type
New chemical entity
ATC codes
L01EA06
Decision
Approved
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 Scemblix 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.
This application was evaluated as part of the Australia-Canada-Singapore-Switzerland (ACSS) Consortium, with work-sharing between TGA, Health Sciences Authority Singapore, and Swissmedic. Each regulator made independent decisions regarding approval (market authorisation) of the new medicine.
| Description | Date |
|---|---|
| Submission dossier accepted and first round evaluation commenced | 27 August 2021 |
| First round evaluation completed | 24 December 2021 |
| Sponsor provides responses on questions raised in first round evaluation | 10 February 2022 |
| Second round evaluation completed | 27 June 2022 |
| Delegate's overall benefit-risk assessment and request for Advisory Committee advice | 28 April 2022 |
| Sponsor's pre-Advisory Committee response | 16 May 2022 |
| Advisory Committee meeting | 2-3 June 2022 |
| Registration decision (Outcome) | 14 July 2022 |
| Completion of administrative activities and registration on ARTG | 15 July 2022 |
| Number of working days from submission dossier acceptance to registration decision* | 171 |
*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
Strength
20 mg and 40 mg
Other ingredients
Lactose monohydrate, microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium, polyvinyl alcohol, titanium dioxide, magnesium stearate, talc, colloidal silicon dioxide, lecithin, xanthan gum, and iron oxide (yellow and red for 20 mg tablet, black and red for 40 mg tablet)
Containers
Blister pack
Pack sizes
20 and 60
Routes of administration
Oral
Dosage
Treatment with Scemblix should be initiated by a physician experienced in the use of anticancer therapies and should be continued as long as clinical benefit is observed or until unacceptable toxicity occurs.
The recommended total daily dose of Scemblix in patients with Philadelphia chromosome-positive chronic myeloid leukaemia (Ph + CML) in chronic phase (CP) is 80 mg and in patients with Ph + CML in CP harbouring the T3151 mutation is 200 mg, taken orally twice daily at approximately 12-hour intervals.
For further information refer to the Product Information.
Pregnancy category
D
Drugs 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.
Drugs 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
Scemblix (asciminib) was approved for the following therapeutic use:
Scemblix is indicated for the treatment of patients 18 years of age and above with:
- Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML) in chronic phase (CP) previously treated with two or more tyrosine kinase inhibitors (see section 5.1 Clinical trials).
- Ph+ CML in CP with the T315I mutation.
What is this medicine and how does it work
Asciminib is an oral and potent inhibitor of Abelson nonreceptor tyrosine kinases/breakpoint cluster region (ABL/BCR): ABL1 tyrosine kinases. Asciminib inhibits the ABL1 kinase activity of the BCR: ABL1 fusion protein, by specifically targeting the ABL myristoyl pocket.
What post-market commitments will the sponsor undertake
- Scemblix (asciminib hydrochloride) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Scemblix 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 Scemblix European Union (EU)-risk management plan (RMP) (version 1.0, dated 15 June 2021, data lock point 6 January 2021), with Australia specific annex (version 1.0, dated 8 July 2021), included with Submission PM-2021-03048-1-6, to be revised to the satisfaction of the TGA, and any subsequent revisions, 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).
Unless agreed separately between the supplier who is the recipient of the approval and the TGA, the first report must be submitted to TGA no later than 15 calendar months after the date of the approval letter. The subsequent reports must be submitted no less frequently than annually from the date of the first submitted report until the period covered by such reports is not less than three years from the date of the approval letter. The annual submission may be made up of two PSURs each covering six months. If the sponsor wishes, the six monthly reports may be submitted separately as they become available.
If the product is approved in the EU during the three years period, reports can be provided in line with the published list of EU reference dates no less frequently than annually from the date of the first submitted report 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. Each report must have been prepared within ninety calendar days of the data lock point for that report.