We will have limited operations from 15:00 Tuesday 24 December 2024 (AEDT) until Thursday 2 January 2025. Find out how to contact us during the holiday period.
Minjuvi
Device/Product name
Minjuvi
Active Ingredient
Tafasitamab
Date of decision
Published
Submission type
New Biological Entity
ATC codes
L01FX12
Decision
Approved for provisional registration.
What was the decision based on
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 Minjuvi was considered favourable for the therapeutic use approved.
What steps were involved in the decision process
Registration timeline
This evaluation was facilitated through Project Orbis, an initiative of the United States (US) Food and Drug Administration (FDA) Oncology Center of Excellence (OCE). Under this project, the FDA and the TGA collaboratively reviewed the application. This innovative evaluation process provided a framework for process alignment and management of evaluation issues in real-time across jurisdictions.
Each regulator agency maintained its regulatory process to make independent decisions about the approval (market authorisation).
| Description | Date |
|---|---|
Designation (Orphan) Designation (Orphan extension) | 15 October 2021 7 March 2022 |
| Determination (Provisional) | 21 February 2022 |
Submission dossier accepted and first round evaluation commenced
| 3 June 2022 |
| First round evaluation completed | 9 November 2022 |
| Sponsor provides responses on questions raised in first round evaluation | 23 December 2022 |
| Second round evaluation completed | 6 March 2023 |
Delegate’s Overall benefit-risk assessment and request for Advisory Committee advice
| 28 April 2023 |
| Sponsor’s pre-Advisory Committee response | 12 May 2023 |
| Advisory Committee meeting | 1 and 2 June 2023 |
| Registration decision (Outcome) | 19 June 2023 |
| Completion of administrative activities and registration on ARTG | 20 June 2023 |
| Number of working days from submission dossier acceptance to registration decision* | 183 |
*Statutory timeframe for standard applications is 255 working days
Date of entry onto ARTG
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.
Dose forms
Powder for solution for infusion.
Strength
200 mg.
Other ingredients
Polysorbate 20, citric acid monohydrate, trehalose dihydrate and sodium citrate dihydrate.
Containers
Vial.
Pack sizes
One vial per carton.
Routes of administration
Intravenous infusion.
Dosage
Minjuvi must be administered by a healthcare professional experienced in treatment of cancer patients.
Recommended pre-medication
A pre-medication to reduce the risk of infusion-related reactions should be administered 30 minutes to 2 hours prior to tafasitamab infusion. For patients not experiencing infusion related reactions during the first 3 infusions, pre-medication is optional for subsequent infusions.
The recommended dose of Minjuvi is 12 mg per kg body weight administered as an intravenous infusion according to the following schedule:
- Cycle 1: infusion on Day 1, 4, 8, 15 and 22 of the cycle.
- Cycles 2 and 3: infusion on Day 1, 8, 15 and 22 of each cycle.
- Cycle 4 until disease progression: infusion on Day 1 and 15 of each cycle.
Each cycle has 28 days.
For further information refer to the Product Information.
Pregnancy category
C
Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. 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.
Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. 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
Minjuvi (tafasitamab) was approved for the following therapeutic use:
The provisionally approved new indication(s) for the medicine(s) are:
Minjuvi is indicated in combination with lenalidomide followed by Minjuvi monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).
This indication was approved via the provisional approval pathway, based on objective response rate and duration of response in a single arm trial. Continued approval for this indication depends on verification and description of clinical benefit in a confirmatory trial.
What is this medicine and how does it work
Tafasitamab is an fragment crystallisable (Fc)-enhanced monoclonal antibody that targets the CD19 antigen expressed on the surface of pre-B and mature B lymphocytes. Upon binding to CD19, tafasitamab mediates B-cell lysis through:
• engagement of immune effector cells like natural killer cells, γδ T cells and phagocytes
• direct induction of cell death (apoptosis)
The Fc modification results in enhanced antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis.
• engagement of immune effector cells like natural killer cells, γδ T cells and phagocytes
• direct induction of cell death (apoptosis)
The Fc modification results in enhanced antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis.
What post-market commitments will the sponsor undertake
- Minjuvi (tafasitamab) is to be included in the Black Triangle Scheme. The PI [Product Information] and CMI [Consumer Medicine Information] for Minjuvi 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 Minjuvi EU [European Union] -risk management plan (RMP) (version 0.7, date 24 June 2021; DLP [data lock point] 30 November 2019), with Australia specific annex (version 0.1, dated July 2021), included with Submission PM-2022-01544-1-6, 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 (revision 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.
- A final clinical study report for MOR208C310 will be submitted for evaluation by the TGA as per the Clinical Study Plan included in the Australia specific annex.
- Laboratory testing & compliance with Certified Product Details (CPD)
- i. All batches of Minjuvi-tafasitamab supplied in Australia must comply with the product details and specifications approved during evaluation and detailed in the Certified Product Details (CPD).
- ii. 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 Results http://www.tga.gov.au/ws-labs-index and periodically in testing reports on the TGA website.
- 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:
- [for the form] https://www.tga.gov.au/form/certified-product-details-cpd-biologicalprescription-medicines.
- [for the CPD guidance] https://www.tga.gov.au/guidance-7-certified-product-details.
- For all injectable products the Product Information must be included with the product as a package insert.
More information
The latest Product Information (PI) and Consumer Medicine Information (CMI) can be found at the Australian Register of Therapeutic Goods (ARTG) search page.
Australian Public Assessment Reports (AusPARs) can be found at the AusPAR search page.
The latest news and updates regarding therapeutic goods regulation can be found at the TGA news page.