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GSK2857916

Extended indication 4L Relapsed/refractory Multiple Myeloma
Therapeutic value No judgement
Registration phase Clinical trials

Product

Active substance GSK2857916
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Multiple Myeloma
Extended indication 4L Relapsed/refractory Multiple Myeloma
Manufacturer GSK
Mechanism of action Antibody-drug conjugate
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks humanized IgG1, an Antibody Drug Conjugated to Microtubule-Disrupting Agent Directed Against B-Cell Maturation Antigen (BCMA).

Registration

Registration route Centralised (EMA)
Type of trajectory Accelerated assessment
Particularity New medicine with Priority Medicines (PRIME)
Submission date August 2019
Expected Registration August 2020
Registration phase Clinical trials

Therapeutic value

Therapeutic value No judgement
Frequency of administration 1 times every 3 weeks
References NCT03525678

Expected patient volume per year

References NKR
Additional remarks NKR (2015): 1.242 patienten met multipel myeloma(max). Gezien relapsed / refractory en overige behandelingen zal het realistische volume echter een stuk lager liggen.

Expected cost per patient per year

There is currently nothing known about the expected cost.

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 3L, 2L, 1L
References https://www.gsk.com/media/5028/q2-2018-slides-hal-barron.pdf

Other information

There is currently no futher information available.