Mogamulizumab

Active substance
Mogamulizumab
Domain
Oncology and Hematology
Reason of inclusion in Horizonscan Geneesmiddelen
New medicine (specialité)
Main indication
Aggressive non-Hodgkin's lymphoma
Extended indication
Poteligeo is indicated for the treatment of adult patients with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy.

1. Product

Proprietary name
Poteligeo
Manufacturer
Kyowa
Mechanism of action
Other
Route of administration
Intravenous
Therapeutical formulation
Intravenous drip
Budgetting framework
Intermural (MSZ)
Additional comments
Humanized monoclonal antibody targeting CC chemokine receptor 4 (CCR4).

2. Registration

Registration route
Centralised (EMA)
Type of trajectory
Normal trajectory
Submission date
November 2017
Expected Registration
November 2018
Orphan drug
Yes
Registration phase
Registered
Additional comments
Indiening gebaseerd op de MAVORIC trial. Positieve CHMP-opinie september 2018. Geregistreerd in november 2018.

3. Therapeutic value

Current treatment options
Systemische chemotherapie
Therapeutic value
Potential added value
Substantiation
Er bestaat een duidelijke unmet clinical need voor de systemische behandeling van patiënten met een CTCL. In Nederland zijn hiervoor nauwelijks behandelingen beschikbaar. Mogalizumab heeft in een gerandomiseerde fase 3 studie hogere ORR en langere PFS laten zien in verband met vorinostat (ASH 2017).
Duration of treatment
Not found
Frequency of administration
1 times a week
Dosage per administration
1 mg/kg
References
NCT01728805
Additional comments
1 mg/kg per week gedurende 4 weken in cyclus 1, daarna 1 maal per 2 weken.

4. Expected patient volume per year

Patient volume

< 10

Market share is generally not included unless otherwise stated.

References
NKR
Additional comments
Incidentie CTCL in 2016 (NKR): 131. Expertopinie schat het aantal patiënten per jaar in op minder dan 10.

5. Expected cost per patient per year

Cost
60,000 - 120,000
References
Scrip
Additional comments
¥155,999 (ongeveer €1.200) per 20mg/5ml. Prijs minimaal/maximaal gebaseerd op 6-12 maanden behandeling van een patiënt van 70kg.

6. Potential total cost per year

Total cost

900,000

This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

Indication extension
Yes
Indication extensions
HTLV-1 associated myelopathy (HAM), Adult T-cell Leukemia/Lymphoma.
References
clinicaltrials.gov
Additional comments
Verwachting van patiëntaantal bij recidief ATLL betreft waarschijnlijk minder dan 5 patiënten per jaar.

9. Other information

There is currently no futher information available.