Pembrolizumab / favezelimab

Extended indication	Patients With Previously Treated Metastatic PD-L1 Positive Colorectal Cancer
Therapeutic value	No estimate possible yet
Registration phase	Clinical trials

Product

Active substance	Pembrolizumab / favezelimab
Domain	Oncology
Reason of inclusion	New medicine (specialité)
Main indication	Colon cancer
Extended indication	Patients With Previously Treated Metastatic PD-L1 Positive Colorectal Cancer
Manufacturer	MSD
Portfolio holder	MSD
Mechanism of action	Combination therapy
Route of administration	Intravenous
Budgetting framework	Intermural (MSZ)
Additional remarks	Co-formulation of PD-1 inhibitor and LAG-3 inhibitor

Registration route	Centralised (EMA)
Particularity	New therapeutical formulation
ATMP	No
Submission date	2024
Expected Registration	2025
Orphan drug	No
Registration phase	Clinical trials

Current treatment options	TAS-102
Therapeutic value	No estimate possible yet
Duration of treatment	Maximal 2 year / years
Frequency of administration	1 times every 3 weeks
Dosage per administration	favezelimab/pembrolizumab 800mg/200mg
References	NCT05064059
Additional remarks	Bispecifiek antilichaam tegen PD-L1 en LAG3 en stimuleert tumorcel afbraak Tcellen via dendritische celactivatie. De Fase 3 studie loopt nog. Fase 1 laten geringe respons zien en te managen toxiciteit.

Patient volume	< 2,085 Market share is generally not included unless otherwise stated.
References	NKR2021(1);
Additional remarks	Gemetastaseerde coloncarcinoom betreft 2.085 patiënten in stadium 4 (1).

Patient volume

< 2,085

Market share is generally not included unless otherwise stated.

References

NKR2021(1);

Additional remarks

Gemetastaseerde coloncarcinoom betreft 2.085 patiënten in stadium 4 (1).

There is currently nothing known about the expected cost.

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.