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Poteligeo
Sponsor
Device/Product name
Poteligeo
Active Ingredient
Mogamulizumab
Date of decision
Published
Submission type
New biological entity
ATC codes
L01XC25
Decision
Approved
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 Poteligeo was considered favourable for the therapeutic use approved.
What steps were involved in the decision process
Registration timeline
The following table summarises the key steps and dates for this application.
| Description | Date |
|---|---|
| Designation (Orphan) | 11 December 2019 |
| Submission dossier accepted and first round evaluation commenced | 1 April 2020 |
| First round evaluation completed | 31 July 2020 |
| Sponsor provides responses on questions raised in first round evaluation | 1 September 2020 |
| Second round evaluation completed | 9 October 2020 |
| Delegate's overall benefit-risk assessment | 20 October 2020 |
| Sponsor's pre-Advisory Committee response | Not applicable |
| Advisory Committee meeting | Not applicable |
| Registration decision (Outcome) | 6 January 2021 |
| Completion of administrative activities and registration on ARTG | 5 February 2021 |
| Number of working days from submission dossier acceptance to registration decision* | 167 |
*Statutory timeframe for standard applications is 255 working days
*The COR-B process has a 175 working day evaluation and decision timeframe.
Date of entry onto ARTG
Original publication date
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
Dose forms
Concentrate solution for intravenous infusion
Strength
20 mg
Other ingredients
Citric acid monohydrate, glycine, polysorbate 80, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), less than 1 mmol sodium per dose, water for injections
Containers
Glass vial
Pack sizes
10 mL vial
Routes of administration
Intravenous infusion
Dosage
The recommended dose is 1 mg/kg mogamulizumab administered as an intravenous infusion over at least 60 minutes. Administration is weekly on days 1, 8, 15 and 22 of the first 28-day cycle, followed by infusions every two weeks on Days 1 and 15 of each subsequent 28-day cycle until disease progression or unacceptable toxicity.
Poteligeo should be administered within 2 days of the scheduled day. If a dose is missed by more than 2 days, the next dose should be administered as soon as possible, after which the dosing schedule should be resumed with doses given based on the new scheduled days.
Pre-medication with anti-pyretic and anti-histamine is recommended for the first Poteligeo infusion. If an infusion reaction occurs, administer pre-medication for subsequent Poteligeo infusions.
For further information refer to the Product Information (PI).
Pregnancy category
CDrugs 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
Poteligeo (mogamulizumab) was approved for the following therapeutic use:
Poteligeo is indicated for the treatment of adult patients (≥ 18 years of age) with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy.
What is this medicine and how does it work
Mogamulizumab is a defucosylated, humanised immunoglobulin G 1 (IgG1) kappa monoclonal antibody that selectively binds to C-C motif chemokine receptor 4 (CCR4), a G protein-coupled receptor for CC chemokines that is involved in the trafficking of lymphocytes to various organs including the skin. CCR4 is expressed on the surface of some T cell malignancies, such as MF and SS as well as Type 2 T helper (Th2) T cells and regulatory T cells (Tregs). Binding of mogamulizumab to CCR4 induces antibody-dependent cellular cytotoxicity (ADCC), resulting in the depletion of target cells.
What post-market commitments will the sponsor undertake
- Poteligeo (mogamulizumab) is to be included in the Black Triangle Scheme. The PI and Consumer Medicines Information (CMI) for Poteligeo 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 mogamulizumab European Union (EU) - Risk Management Plan (RMP) (version 1.0, dated 17 September 2018; data lock point 31 December 2016), with Australian Specific Annex (version 1.1, dated 31 August 2020), included with submission PM-2020-00700-1-6, 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).
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.