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Tremelimumab

Extended indication Untreated extensive-stage small cell lung cancer (SCLC) in combination with durvalumab and chemotherapy.
Therapeutic value No judgement
Registration phase Clinical trials

Product

Active substance Tremelimumab
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Lung cancer
Extended indication Untreated extensive-stage small cell lung cancer (SCLC) in combination with durvalumab and chemotherapy.
Manufacturer AstraZeneca
Mechanism of action CTLA-4 antibody
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date December 2019
Expected Registration December 2020
Orphan drug No
Registration phase Clinical trials
Additional remarks Fabrikant verwacht indiening in Q4 2019 en registratie in 2020.

Therapeutic value

Current treatment options Chemotherapie en immuuntherapie
Therapeutic value No judgement
Frequency of administration 1 times every 3 weeks
Dosage per administration 75 mg
References NCT03043872

Expected patient volume per year

Patient volume

500 - 700

Market share is generally not included unless otherwise stated.
References NKR
Additional remarks In 2016 werden er 1.118 diagnoses stadium 4 SCLC geregistreerd. Inschatting patientvolume is sterk afhankelijk van precieze indicatie. De inschatting is dat er uiteindelijk 500-700 patiënten in aanmerking kunnen komen voor deze behandeling (gelijk aan de inschatting voor atezolizumab en pembrolizumab).

Expected cost per patient per year

References G-standaard
Additional remarks De kosten van tremelimumab zijn nog niet bekend De dosis durvalumab is 1.500 mg. Prijs per toediening is (3 * €2.328) = €6.984. De eerste 4 cycles wordt dit elke 3 weken gegeven (met of zonder tremelimumab), daarna nog een keer de combi bij 16 weken (dus 5*de combinatie. (prijs tot 16 weken is dus 5 * €6.984 = €34.920). Daarna elke 4 weken durvalumab monotherapie. Voor 6 maanden is dit (26-16) / 4 * €6.984 = €17.460 + €34.920= €52.380; voor 52 weken is dit €52.380 + 26 / 4 * €6.984 = €97.776. Durvalumab is opgenomen in de sluis voor oncologische indicaties tot er is gekomen tot een financieel arrangement.

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

Indication extension Yes
Indication extensions Nog voor veel indicaties in ontwikkeling. Meerdere studies teruggetrokken, 1 PhIII studie loopt nog: Monotherapy Versus Single-agent Cytotoxic Chemotherapy in Patients With Mutant EGFR Non-small Cell Lung Cancer (NSCLC) After Failure of at Least 1 Previous EGFR-directed Tyrosine Kinase Inhibitor (TKI) and Platinum-doublet Chemotherapy.

Other information

There is currently no futher information available.