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Notification report


Full notification file


General information

Notification Number
B/HU/17/04

Member State to which the notification was sent
Hungary

Date of acknowledgement from the Member State Competent Authority
10/02/2017

Title of the Project
A Phase 2, Multicenter, Open-label, Singlearm Trial to Evaluate the Correlation Between Objective Response Rate and Baseline Intratumoral CD8+ Cell Density in Subjects With Unresected Stage IIIB to IVM1c Melanoma Treated with Talimogene Laherparepvec

Proposed period of release:
01/03/2015 to 28/02/2019

Name of the Institute(s) or Company(ies)
Amgen Limited, UK, On behalf of Amgen Inc. (study sponsor);


3. Is the same GMO release planned elsewhere in the Community?
Yes:
Belgium; Germany; Spain; France; Greece; Netherlands; Portugal; Sweden;

Has the same GMO been notified elsewhere by the same notifier?
Yes

If yes, notification number(s):
B/BE/15/BVW1; B/BE/15/BVW2; B/DE/14/PEI2133; B/DE/14/PEI2194; B/DE/16/PEI2623; B/ES/14/05; B/ES/14/06; B/ES/14/08; B/ES/15/04; B/ES/15/07; B/ES/15/14; B/ES/16/01; B/FR/15/GT01; B/FR/15/GT06; B/FR/15/GT07; B/HU/14/01; B/PT/16/01; B/PT/16/03; B/SE/14/EU-2014-000185-22;

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
Genus: Simplexvirus
Species: Talimogene laherparepvec is a recombinant of a wild type Herpes simplex virus 1 (HSV-1) strain JS1, with genes ICP34.5 and ICP47 deleted and hGM-CSF inserted


Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
HSV-1SimplexvirusHSV-1-JS1 (ECACC Accession Number 01010209)-

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known