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Qinlock

21 July 2020

The Australian Prescription Medicine Decision Summary provides a short overview of the TGA's evaluation process leading to the registration of a new prescription medicine on the Australian Register of Therapeutic Goods (ARTG).

More in-depth information about the evaluation will be available in the Australian Public Assessment Report (AusPAR) for a particular prescription medicine, which can be found on the AusPAR search page once published.

Australian prescription medicine decision summary

Summary of submission

Submission type
New chemical entity
Product name
Qinlock
Active ingredients
Ripretinib
ATC codes
Not yet assigned
Decision
Approved
Date of decision
10 July 2020
Date of entry onto ARTG
13 July 2020
ARTG numbers
327899
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
Sponsor
TudorRose Consulting Pty Ltd
Sponsor address
3 Grandview Avenue, Point Cook, VIC, 3030
Dose forms
Tablet
Strength
50 mg
Other ingredients
Crospovidone; hypromellose acetate succinate; lactose monohydrate; magnesium stearate; microcrystalline cellulose; silicon dioxide
Containers
Bottle
Pack sizes
90 tablets
Routes of administration
Oral
Dosage

The recommended dosage of Qinlock is 150 mg (three 50 mg tablets) orally once daily with or without food until disease progression or unacceptable toxicity.

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.

What was approved?

Qinlock (ripretinib) was approved for the following therapeutic use:

Qinlock is a kinase inhibitor indicated for the treatment of adult patients with advanced gastrointestinal stromal tumours (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.

What is this medicine and how does it work?

What was the decision based on?

What steps were involved in the decision process?

What post-market commitments will the sponsor undertake?

  • Qinlock (ripretinib) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Qinlock 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 Qinlock Core-Risk Management Plan (RMP) (version 0.2, dated 22 May 2020, data lock point 31 May 2019), with Australian specific Annex (version 1.0, dated 16 January 2020), included with submission PM-2019-05961-1-4, and any subsequent revisions, as agreed with 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).

Unless agreed separately between the supplier who is the recipient of the approval and the TGA, the first report must be submitted to the 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 European Union (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 (Rev 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.

Further information

The latest Product Information (PI) and Consumer Medicines Information (CMI) can be found at: ARTG search.

Australian Public Assessment Reports (AusPARs) can be found at: AusPAR search.

The latest news and updates regarding therapeutic goods regulation can be found at: TGA news room.