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Polivy

28 October 2019

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

Product name
Polivy
Active ingredients
Polatuzumab vedotin
ATC codes
N/A
Decision
Approved
Date of decision
18 October 2019
Date of entry onto ARTG
21 October 2019
ARTG numbers
314866
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
Roche Products Pty Limited
Sponsor address
30-34 Hickson Road, Sydney NSW 2000
Dose forms
Powder for injection
Strength
140 mg
Other ingredients
Succinic acid, sodium hydroxide, sucrose, polysorbate 20
Containers
Vial
Pack sizes
1
Routes of administration
Intravenous infusion
Dosage

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.

What was approved?

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.

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?

  • 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.

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.