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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|| |
|Date of decision|| |
18 October 2019
|Date of entry onto ARTG|| |
21 October 2019
|ARTG numbers|| |
|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
Roche Products Pty Limited
|Sponsor address|| |
30-34 Hickson Road, Sydney NSW 2000
|Dose forms|| |
Powder for injection
|Other ingredients|| |
Succinic acid, sodium hydroxide, sucrose, polysorbate 20
|Pack sizes|| |
|Routes of administration|| |
The recommended dose of Polivy is 1.8 mg/kg given as an intravenous infusion every 21 days in combination with bendamustine and rituximab for 6 cycles.
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.
Polivy (polatuzumab vedotin) was approved for the following therapeutic use:
Polivy in combination with bendamustine and rituximab is indicated for the treatment of previously treated adult patients with diffuse large B-cell lymphoma who are not candidates for hematopoietic stem cell transplant.
Polatuzumab vedotin is a cancer treatment.
Polatuzumab vedotin is a CD79b-targeted antibody-drug conjugate that preferentially delivers an anti-mitotic agent (monomethyl auristatin E, or MMAE) to B-cells, which results in the killing of malignant B-cells.
The polatuzumab vedotin molecule consists of MMAE covalently attached to a humanised immunoglobulin G1 (IgG1) monoclonal antibody via a cleavable linker. The monoclonal antibody binds with nanomolar affinity to CD79b, a cell surface component of the B cell receptor. CD79b expression is restricted to normal cells within the B-cell lineage (with the exception of plasma cells) and malignant B-cells; it is expressed in > 95% of diffuse large B-cell lymphoma (DLBCL). Upon binding CD79b, polatuzumab vedotin is internalised and the linker is cleaved by lysosomal proteases to enable intracellular delivery of MMAE. MMAE binds to microtubules and kills dividing cells by inhibiting cell division and inducing apoptosis.
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 Polivy was considered favourable for the therapeutic use approved.
The following table summarises the key steps and dates for this application.
|Submission dossier accepted and first round evaluation commenced||15 April 2019|
|Evaluation completed||17 September 2019|
|Delegate's overall benefit-risk assessment and request for Advisory Committee advice||16 September 2019|
|Sponsor's pre-Advisory Committee response||N/A|
|Advisory Committee meeting||N/A|
|Registration decision (Outcome)||18 October 2019|
|Completion of administrative activities and registration on ARTG||21 October 2019|
|Number of working days from submission dossier acceptance to registration decision*||130|
*Statutory timeframe for standard applications is 255 working days
- Polivy (polatuzumab vedotin) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Polivy 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 Polivy European Union-Risk Management Plan (EU-RMP) (version 1.0, dated 17 December 2018, data lock point 7 September 2018), with Australian Specific Annex (version 1.1, dated June 2019), included with submission PM-2019-00471-1-6, and any subsequent revisions, as agreed with the TGA will be implemented in Australia.
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 this 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 this approval letter. The annual submission may be made up of two periodic safety update reports (PSURs) each covering six months. If the sponsor wishes, the six monthly reports may be submitted separately as they become available.
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.
- Batch release testing & compliance with Certified Product Details (CPD)
- It is a condition of registration that all batches of Polivy imported into Australia must comply with the product details and specifications approved during evaluation and detailed in the Certified Product Details (CPD).
- It is a condition of registration that up to 5 initial batches of Polivy imported into 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 product 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 on TGA testing of biological medicines is available at https://www.tga.gov.au/publication/testing-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 you are notified in writing of any variation.
- Certified Product Details
The Certified Product Details (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 CPD should be emailed to Biochemistry.Testing@health.gov.au as a single PDF document.
- The sponsor will provide a study report of trial GO39942 to Therapeutic Goods Administration for evaluation no later than this trial is first submitted to either the United States (US) Food and Drug Administration (FDA), European Medicines Agency (EMA) or Health Canada.
- The register entry will include as a condition of registration a shelf life of 12 months at 2 to 8 degrees centigrade as specified in the Biological evaluation.
- For all injectable products the Product Information must be included with the product as a package insert.