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Axicabtagene ciloleucel

Yescarta

Extended indication Treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more line
Therapeutic value No judgement
Registration phase Registration application pending

Product

Active substance Axicabtagene ciloleucel
Domain Oncology and Hematology
Main indication Lymphoma
Extended indication Treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma (transformed follicular lymphoma, or TFL).
Proprietary name Yescarta
Manufacturer Gilead
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks Geregistreerd bij de FDA in oktober 2017.

Registration

Registration route Centralised (EMA)
Type of trajectory Accelerated assessment
Particularity New medicine with Priority Medicines (PRIME)
Submission date September 2017
Expected Registration August 2018
Orphan drug Yes
Registration phase Registration application pending

Therapeutic value

Therapeutic value No judgement
Additional remarks Eenmalige infusie

Expected patient volume per year

References NKR; Raut et al. South Asian J Cancer. 2014 Jan-Mar; 3(1): 66–70; Casulo et al. Blood 2015 125:40-47
Additional remarks NKR (2015): 1.399 DLBLC en varianten (incl. PMBCL); 474 FL. Ongeveer 50 tot 60% van de patiënten met DLBCL behalen complete remissie na eerstelijnstherapie. 30 tot 40% relapse en 10% refractory. Transformatie van FL in 24-70%. 1.399x0,5+474x0,7=1.031 patiënten bij deze indicatie. Potentieel dus veel patiënten maar zal gezien de latere lijns behandeling initieel waarschijnlijk bij een kleinere groep patiënten worden ingezet.

Expected cost per patient per year

Cost 300,000.00
References Persbericht Gilead VS
Additional remarks Lijstprijs in EU nog niet bekend. Lijstprijs in de VS is $373.000. Schatting op basis van US prijs: 300.000 pppj

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.