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A practical guide to the handling and administration of talimogene laherparepvec in Europe

Authors Harrington KJ, Michielin O, Malvehy J, Pezzani Grüter I, Grove L, Frauchiger AL, Dummer R

Received 2 February 2017

Accepted for publication 6 June 2017

Published 2 August 2017 Volume 2017:10 Pages 3867—3880

DOI https://doi.org/10.2147/OTT.S133699

Checked for plagiarism Yes

Review by Single-blind

Peer reviewers approved by Dr Akshita Wason

Peer reviewer comments 3

Editor who approved publication: Dr Tohru Yamada

Kevin J Harrington,1 Olivier Michielin,2 Josep Malvehy,3,4 Isabella Pezzani Grüter,5 Lorna Grove,6 Anna Lisa Frauchiger,7 Reinhard Dummer7

1NIHR Biomedical Research Centre, The Institute of Cancer Research/The Royal Marsden Hospital, London, UK; 2Department of Oncology, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland; 3Hospital Clinic de Barcelona, IDIBAPS, CIBER de enfermedades raras, Barcelona, Spain; 4FIS del Instituto de Salud Carlos III, Madrid, Spain; 5Department of Research and Development, Amgen Switzerland AG, Zug, Switzerland; 6Head and Neck Unit, The Royal Marsden Hospital, London, UK; 7Skin Cancer Centre/Dermatology Clinic, Universitätsspital Zürich, Zurich, Switzerland

Abstract: Talimogene laherparepvec is a herpes simplex virus-1-based intralesional oncolytic immunotherapy and is the first oncolytic virus to be approved in Europe. It is indicated for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (stage IIIB, IIIC, and IVM1a) with no bone, brain, lung, or other visceral disease. Talimogene laherparepvec is a genetically modified viral therapy, and its handling needs special attention due to its deep freeze, cold-chain requirements, its potential for viral shedding, and its administration by direct intralesional injection. This review provides a practical overview of handling, storage, and administration procedures for this agent in Europe. Talimogene laherparepvec vials should be transported/stored frozen at a temperature of –90°C to –70°C, and once thawed, vials must not be refrozen. Universal precautions for preparation, administration, and handling should be followed to avoid accidental exposure. Health care providers should wear personal protective equipment, and materials that come into contact with talimogene laherparepvec should be disposed of in accordance with local institutional procedures. Individuals who are immunocompromised or pregnant should not prepare or administer this agent. Talimogene laherparepvec is administered by intralesional injection into cutaneous, subcutaneous, and/or nodal lesions that are visible, palpable, or detectable by ultrasound. Treatment should be continued for ≥6 months. As with other immunotherapies, patients may experience an increase in the size of existing lesion(s) or the appearance of new lesions (ie, progression) prior to achieving a response (“pseudo-progression”). As several health care professionals (eg, physicians [dermatologists, surgeons, oncologists, radiologists], pharmacists, nurses) are involved in different stages of the process, there is a need for good interdisciplinary collaboration when using talimogene laherparepvec. Although there are specific requirements for this agent’s storage, handling, administration, and disposal, these can be effectively managed in a real-world clinical setting through the implementation of training programs and straightforward standard operating procedures.

Keywords: herpes simplex virus, intralesional injection, melanoma, oncolytic immunotherapy, practical considerations, talimogene laherparepvec

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