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Retifanlimab

Zynyz

Extended indication Patiënten met inoperabele, lokaal gevorderd of gemetastaseerd plaveiselcarcinoom van het anale kanaal.
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Retifanlimab
Domain Oncology
Reason of inclusion New medicine (specialité)
Main indication Oncology other
Extended indication Patiënten met inoperabele, lokaal gevorderd of gemetastaseerd plaveiselcarcinoom van het anale kanaal.
Proprietary name Zynyz
Manufacturer Incyte
Mechanism of action PD-1 / PD-L1 inhibitor
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Centre of expertise NKI-AVL official expert center.

Registration

Registration route Centralised (EMA)
ATMP No
Submission date December 2024
Expected Registration November 2025
Orphan drug Yes
Registration phase Clinical trials
Additional remarks Registration will be based on results of the POD1UM-303 phase 3, randomized, double blind, placebo controlled, no prior systemic therapy (only adjuvant CT allowed), stratified by PD-L1 expr.(<%, >=1%). Arms: reti + Pt-CT versus Pt-CT.  Primary endpoint: PFS Secondary: OS, ORR, DOR, safety No results yet

Therapeutic value

Current treatment options Current palliative care: mostly chemo-radiation.
Therapeutic value No estimate possible yet
Substantiation Er zijn nog geen gegevens bekend. Indien de therapeutische waarde gelijk blijkt aan 5FU/capecitabine zal het ingezet worden op het moment dat dit niet veilig is om toe te dienen. In het geval van bijvoorbeeld symptomen van hartfalen of cardiovasculaire bijwerkingen.
Frequency of administration 1 times every 4 weeks
Dosage per administration 500 mg
References NCT03597295, NCT04472429

Expected patient volume per year

Patient volume

20 - 30

Market share is generally not included unless otherwise stated.
References Oncoline
Additional remarks Approx. 300 new patients/year of which 10-15% locally advanced/metast. (30-45 patients) onset of disease: approx. 55-60 year, so older population

Expected cost per patient per year

Additional remarks Mogelijk vergelijkbare kosten met andere PD-1 remmers.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.