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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
|Submission type|| |
New biological entity
|Product name|| |
|Active ingredients|| |
|ATC codes|| |
Approved for provisional registration
|Date of decision|| |
2 July 2020
|Date of entry onto ARTG|| |
17 July 2020
|ARTG numbers|| |
|Black Triangle Scheme|| |
Yes. As a provisionally registered product, this medicine will remain in the Black Triangle Scheme for the duration of its provisional registration
Sanofi-Aventis Pty Ltd
|Sponsor address|| |
12-24 Talavera Road, Macquarie Park, NSW 2113
|Dose forms|| |
Concentrate for solution for infusion
350 mg/7 mL
|Other ingredients|| |
Histidine, histidine monohydrochloride monohydrate, sucrose, proline, polysorbate 80, water for injections
|Pack sizes|| |
|Routes of administration|| |
Treatment must be initiated and supervised by physicians experienced in the treatment of cancer.
The recommended dose is 350 mg cemiplimab every 3 weeks (Q3W) administered as an intravenous infusion over 30 minutes. Treatment may be continued until disease progression or unacceptable toxicity.
For further information refer to the Product Information.
|Pregnancy category|| |
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.
Libtayo (cemiplimab) was provisionally approved for the following therapeutic use:
Libtayo as monotherapy has provisional approval in Australia for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (mCSCC or laCSCC) who are not candidates for curative surgery or curative radiation.
The decision to approve this indication has been made on the basis of objective response rate (ORR) and duration of response from single arm clinical studies. The sponsor is required to submit further clinical data to confirm the clinical benefit of the medicine.
The provisional registration period for the above medicine is two years starting on the day specified in the ARTG certificate of registration.
The following table summarises the key steps and dates for this application.
|Designation (Provisional)||16 July 2019|
|Submission dossier accepted and first round evaluation commenced||30 August 2019|
|First round evaluation completed||31 January 2020|
|Sponsor provides responses on questions raised in first round evaluation||2 March 2020|
|Second round evaluation completed||9 April 2020|
|Delegate's overall benefit-risk assessment||19 June 2020|
|Sponsor's pre-Advisory Committee response||Not applicable|
|Advisory Committee meeting||Not applicable|
|Registration decision (Outcome)||2 July 2020|
|Completion of administrative activities and registration on ARTG||17 July 2020|
|Number of working days from submission dossier acceptance to registration decision*||195|
*Statutory timeframe for standard applications is 255 working days
- Libtayo (cemiplimab) is to be included in the Black Triangle Scheme. The Product Information and Consumer Medicines Information for Libtayo must include the black triangle symbol and mandatory accompanying text for the products entire period of provisional registration.
- Confirmatory trial data (as identified in the sponsor's plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that registration would commence) must be provided.
Specifically, the sponsor must conduct studies as described in the clinical study plan in version 1.1 (date 28 February 2020) of the Australian specific Annex. The following study report(s) should be submitted to the TGA:
- Study R2810-ONC-1540, by 31 October 2022
- Study R2810-ONC-1540 (Group 6), by 31 March 2023
Further guidance for sponsors is available on the TGA website.
- Batch release testing and compliance with Certified Product Details (CPD)
- It is a condition of registration that all batches of Libtayo (cemiplimab) imported into/manufactured in Australia must comply with the product details and specifications approved during evaluation and detailed in the CPD.
- It is a condition of registration that each batch of Libtayo (cemiplimab) imported into/manufactured in Australia is not released for sale until samples and/or the manufacturer's release data have been assessed and endorsed for release by the TGA Laboratories Branch. Outcomes of laboratory testing are published biannually in the TGA Database of Laboratory Testing Results.
- The sponsor should be prepared to provide samples, reference materials and documentary evidence as defined by the TGA Laboratories branch. The sponsor must contact Biochemistry.Testing@health.gov.au for specific material requirements related to the batch release testing/assessment of the product. More information is available at Testing of biological medicines
This batch release condition will be reviewed and may be modified on the basis of actual batch quality and consistency. This condition remains in place until the sponsor is notified in writing of any variation.
- Certified Product Details
The CPD, as described in Guidance 7: Certified Product Details of the Australian Regulatory Guidelines for Prescription Medicines (ARGPM), in PDF format, for the above products should be provided upon registration of these therapeutic goods. In addition, an updated CPD should be provided when changes to finished product specifications and test methods are approved in a Category 3 application or notified through a self-assessable change.
- The Libtayo Eurpean Union-risk management plan (EU-RMP) (version 1.0, dated 26 April 2019, data lock point 10 October 2018), with Australian specific Annex (version 1.1, dated 28 February 2020), included with submission PM-2019-03270-1-4, 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). 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 (Rev 1), Part VII.B Structures and processes.
Note that submission of a PSUR does not constitute an application to vary the registration.
- For all injectable products the Product Information must be included with the product as a package insert.