Back

Notification report


Full notification file


General information

Notification Number
B/ES/19/22

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
30/10/2019

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?
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/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