Retifanlimab

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 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

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

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

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

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

There is currently nothing known about the possible total cost.

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.