27 October 2016 EMA/693934/2016 Inspections, Human Medicines Pharmacovigilance Division Committees and Inspections Department

Scientific recommendation on classification of advanced therapy medicinal products Article 17 – Regulation (EC) No 1394/2007

Disclaimer: This document is a summary for public release of a scientific recommendation on classification of advanced therapy medicinal products. The original text adopted by the Committee for Advanced Therapies (CAT) has been redacted to delete commercially confidential information. The present scientific recommendation refers exclusively to the case as presented to the European Medicines Agency (EMA) without prejudice to future evaluations by the Agency. It is stressed that the scientific recommendation on advanced therapy classification does not amount to any endorsement of the plausibility of the product, including the mode of action or therapeutic indication(s) claimed by the applicant.

Brief description (or name when available) of the active substance(s) Tumour selectively replicating oncolytic adenovirus expressing tumour necrosis factor alpha (TNFα) and interleukin 2 (IL2).

Brief description of the finished product Concentrate of a solution for injection.

Proposed indication Metastatic melanoma and other solid tumours.

EMA/CAT conclusion The committee adopted on 7 October 2016 the following scientific recommendation. On the basis that the product:

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the Product contains an active substance which contains a recombinant nucleic acid administered to human beings with a view to adding a genetic sequence,



Its therapeutic effect relates directly to the product of genetic expression of this sequence,

the EMA/CAT considers that the Product falls within the definition of a gene therapy medicinal product.

Scientific recommendation on classification of advanced therapy medicinal products EMA/693934/2016

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Tumour selectively replicating oncolytic adenovirus expressing tumor ...

Oct 27, 2016 - An agency of the European Union. Telephone +44 ... Send a question via our website www.ema.europa.eu/contact ... EMA/CAT conclusion.

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