Notification report

Full notification file

General information

Notification Number

Member State to which the notification was sent

Date of acknowledgement from the Member State Competent Authority

Title of the Project
Phase 2 Study of Talimogene Laherparepvec in Combination With Pembrolizumab in Subjects With Unresectable/Metastatic Stage IIIB-IVM1d Melanoma Who Have Progressed on Prior Anti-PD-1 Based Therapy (20180115)

Proposed period of release:
01/05/2020 to 31/12/2024

Name of the Institute(s) or Company(ies)
Amgen B.V., NL, ;

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

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

If yes, notification number(s):
B/BE/14/BVW1; B/BE/15/BVW1; B/BE/15/BVW2; B/BE/16/BVW1; B/BE/17/BVW2; B/DE/14/PEI2133; B/DE/14/PEI2194; B/DE/16/PEI2468; B/DE/16/PEI2623; B/DE/17/PEI3191; 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 hGMCSF 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