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Sugemalimab

Cejemly

Extended indication Cejemly in combination with platinum-based chemotherapy is indicated for the first‑line treatment of
Therapeutic value No estimate possible yet
Total cost 105,550,000.00
Registration phase Positive CHMP opinion

Product

Active substance Sugemalimab
Domain Oncology
Reason of inclusion New medicine (specialité)
Main indication Lung cancer
Extended indication Cejemly in combination with platinum-based chemotherapy is indicated for the first‑line treatment of adults with metastatic non‑small‑cell lung cancer (NSCLC) with no sensitising EGFR mutations, or ALK, ROS1 or RET genomic tumour aberrations.
Proprietary name Cejemly
Manufacturer CStone
Mechanism of action PD-1 / PD-L1 inhibitor
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date February 2023
Expected Registration August 2024
Orphan drug No
Registration phase Positive CHMP opinion
Additional remarks Positieve CHMP-opinie mei 2024

Therapeutic value

Current treatment options Overige PD-1/PD-L! remmers
Therapeutic value No estimate possible yet
Substantiation De verwachting is dat dit geneesmiddel een vergelijkbare waarde zal hebben aan andere pdl-1 remmers. Er is echter geen head-to-head studie gedaan.
Frequency of administration 1 times every 3 weeks
Dosage per administration 1200 mg
References NCT03789604 (GEMSTONE-302)

Expected patient volume per year

Patient volume

< 2,111

Market share is generally not included unless otherwise stated.
References NKR2020 (1); Pakketadvies Atezolizumab (2);
Additional remarks Jaarlijks presenteren er ongeveer 5.027 patiënten per jaar met NSCLC stadium IV (1). Hiervan ontvangt 60% een eerstelijnsbehandeling (3.016) waarvan 70% chemotherapie 2.111 (2). Gezien de overige behandelopties met immuuntherapie in de eerste lijn zal er slechts een deel van de patiënten voor deze behandeling in aanmerking komen.

Expected cost per patient per year

Cost 40,000.00 - 60,000.00
Additional remarks Afhankelijk van de studieresultaten wordt er verwacht dat de kosten van deze behandeling in lijn liggen met andere PD-L1 remmers

Potential total cost per year

Total cost

105,550,000.00

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

Off label use No

Indication extension

Indication extension Yes
Indication extensions Maagkanker, oesophaguskanker
References Adis insight

Other information

There is currently no futher information available.