Extended indication

Monotherapy for the treatment of adult patients with Merkel Cell Carcinoma with distant metastatic d

Therapeutic value

No estimate possible yet

Total cost


Registration phase

Registration application pending


Active substance




Reason of inclusion

New medicine (specialité)

Main indication

Oncology other

Extended indication

Monotherapy for the treatment of adult patients with Merkel Cell Carcinoma with distant metastatic disease or recurrent advanced locoregional disease not amenable to surgery or radiation



Mechanism of action

Proteasome inhibitor

Route of administration


Therapeutical formulation


Budgetting framework

Intermural (MSZ)

Additional remarks
Retifanlimab is a humanized, anti–programmed cell death protein-1 (PD-1) monoclonal antibody


Registration route

Centralised (EMA)

Type of trajectory

Conditional marketing authorisation



Submission date

March 2023

Expected Registration

May 2024

Orphan drug


Registration phase

Registration application pending

Therapeutic value

Current treatment options

Chemotherapie: cisplatin of carboplatin/etoposide met of zonder RT. Nu met name avelumab bij irresectabel stadium iii-IV MCC.

Therapeutic value

No estimate possible yet


Er is enkel een inidrecte vergelijking met avelumab mogelijk. De PODIUM 201 trial liet een ORR van 52% zien voor retifanlimab. Avelumab liet een ORR van 40% zien. Daarnaast was er een complete respons % 18.5 (retifanlimab) versus16,4 (avelumab). Dit ging om chemo-naïeve MCC patiënten. Het bijwerkingenprofiel van retifanlimab is vergelijkbaar met andere anti PD (L)-1's. Een voordeel is daarnaast dat retifanlimab minder frequent toegediend hoeft te worden.

Frequency of administration

1 times a month

Dosage per administration

500 mg

POD1UM-201: A Phase 2 Study of Retifanlimab(INCMGA00012) in Locally Advanced or Metastatic Merkel Cell Carcinoma,European Society for Medical Oncology Virtual Congress 2020 September 19–21, 2020, P1089, G. Grignani et al 
(Javelin-220 trial: Ott PA, et al. Ann Oncol. 2017;28:1036-41

Expected patient volume per year

Patient volume

10 - 15

Market share is generally not included unless otherwise stated.

(1) A. Van Akkooi, Nederlands Tijdschrift voor Dermatologie en Venereologie | jaargang 31 | nummer 8 | september 2021; (2) IKNL2021; Expertopinie(3);
Additional remarks
Incidentie MCC (alle stadia) stijgt, inmiddels circa150 tot 200 per jaar in Nederland (1). In 2021 waren er 43 diagnoses in stadium III en 10 diagnoses stadium IV. Het systemisch behandelen van MCC komt in vier centra voor en betreft 10 tot 15 incidente patiënten per jaar (3).

Expected cost per patient per year


40,000.00 - 60,000.00

Additional remarks
Vergelijkbare kosten met andere PD-1 remmers. Mogelijk tussen de €40.000 en €60.000 per jaar.

Potential total cost per year

Total cost


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.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension


Indication extensions

Endometrial cancer; Non-small cell lung cancer

Adis insight

Other information

There is currently no futher information available.