Columvi

• Columvi (glofitamab) is to be included in the Black Triangle Scheme. The PI [Product Information] and CMI [Consumer Medicines Information] for Columvi must include the black triangle symbol and mandatory accompanying text for five years, or the product’s entire period of provisional registration, whichever is longer.
• The glofitamab EU [European Union]-Risk Management Plan (RMP) (version 1.0; (date 22 March 2022; DLP [data lock point] 4 March 2022)), with Australia Specific Annex (version 1.0, dated 27 May 2022), included with submission PM-2022-01989-1-6, 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 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, or the entire period of provisional registration, whichever is longer.

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.

• Laboratory testing & compliance with Certified Product Details (CPD)
  1. All batches of Columvi (glofitamab) supplied in Australia must comply with the product details and specifications approved during evaluation and detailed in the Certified Product Details (CPD).
  2. When requested by the TGA, the Sponsor should be prepared to provide product samples, specified reference materials and documentary evidence to enable the TGA to conduct laboratory testing on the Product. Outcomes of laboratory testing are published biannually in the TGA Database of Laboratory Testing Resultshttp://www.tga.gov.au/ws-labs-index and periodically in testing reports on the TGA website.
• 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.

A template for preparation of CPD for biological prescription medicines can be obtained from the TGA website

• The sponsor must conduct studies as described in the clinical study plan in version 1.0 (dated 27 May 2022) of the Australia specific annex. The following study reports should be submitted to TGA within 6 months of completion:
  • Study GO41944 by first quarter of 2024
  • Study NP30179 by second quarter of 2023
  • Further data from cohort D5 should be submitted in any application for review of provisional registration.

Further information

The latest Product Information (PI) and Consumer Medicines Information (CMI) can be found at the Australian Register of Therapeutic Goods (ARTG) search.

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

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