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International Nonproprietary Names for Pharmaceutical Substances (INN) WHO Drug Information, Vol. 35, No. 2, 2021 Proposed INN: List 125 International Nonproprietary Names for Pharmaceutical Substances (INN) Notice is hereby given that, in accordance with article 3 of the Procedure for the Selection of Recommended International Nonproprietary Names for Pharmaceutical Substances, the names given in the list on the following pages are under consideration by the World Health Organization as Proposed International Nonproprietary Names. The inclusion of a name in the lists of Proposed International Nonproprietary Names does not imply any recommendation of the use of the substance in medicine or pharmacy. Lists of Proposed (1–117) and Recommended (1–78) International Nonproprietary Names can be found in Cumulative List No. 17, 2017 (available in CD-ROM only). The statements indicating action and use are based largely on information supplied by the manufacturer. This information is merely meant to provide an indication of the potential use of new substances at the time they are accorded Proposed International Nonproprietary Names. WHO is not in a position either to uphold these statements or to comment on the efficacy of the action claimed. Because of their provisional nature, these descriptors will neither be revised nor included in the Cumulative Lists of INNs. Dénominations communes internationales des Substances pharmaceutiques (DCI) Il est notifié que, conformément aux dispositions de l'article 3 de la Procédure à suivre en vue du choix de Dénominations communes internationales recommandées pour les Substances pharmaceutiques les dénominations ci-dessous sont mises à l'étude par l'Organisation mondiale de la Santé en tant que dénominations communes internationales proposées. L'inclusion d'une dénomination dans les listes de DCI proposées n'implique aucune recommandation en vue de l'utilisation de la substance correspondante en médecine ou en pharmacie. On trouvera d'autres listes de Dénominations communes internationales proposées (1–117) et recommandées (1–78) dans la Liste récapitulative No. 17, 2017 (disponible sur CD-ROM seulement). Les mentions indiquant les propriétés et les indications des substances sont fondées sur les renseignements communiqués par le fabricant. Elles ne visent qu'à donner une idée de l'utilisation potentielle des nouvelles substances au moment où elles sont l'objet de propositions de DCI. L'OMS n'est pas en mesure de confirmer ces déclarations ni de faire de commentaires sur l'efficacité du mode d'action ainsi décrit. En raison de leur caractère provisoire, ces informations ne figureront pas dans les listes récapitulatives de DCI. Denominaciones Comunes Internacionales para las Sustancias Farmacéuticas (DCI) De conformidad con lo que dispone el párrafo 3 del "Procedimiento de Selección de Denominaciones Comunes Internacionales Recomendadas para las Sustancias Farmacéuticas", se comunica por el presente anuncio que las denominaciones detalladas en las páginas siguientes están sometidas a estudio por la Organización Mundial de La Salud como Denominaciones Comunes Internacionales 361 Proposed INN: List 125 WHO Drug Information, Vol. 35, No. 2, 2021 Propuestas. La inclusión de una denominación en las listas de las DCI Propuestas no supone recomendación alguna en favor del empleo de la sustancia respectiva en medicina o en farmacia. Las listas de Denominaciones Comunes Internacionales Propuestas (1–117) y Recomendadas (1–78) se encuentran reunidas en Cumulative List No. 17, 2017 (disponible sólo en CD-ROM). Las indicaciones sobre acción y uso que aparecen se basan principalmente en la información facilitada por los fabricantes. Esta información tiene por objeto dar una idea únicamente de las posibilidades de aplicación de las nuevas sustancias a las que se asigna una DCI Propuesta. La OMS no está facultada para respaldar esas indicaciones ni para formular comentarios sobre la eficacia de la acción que se atribuye al producto. Debido a su carácter provisional, esos datos descriptivos no deben incluirse en las listas recapitulativas de DCI. Proposed International Nonproprietary Names: List 125 Comments on, or formal objections to, the proposed names may be forwarded by any person to the INN Programme of the World Health Organization within four months of the date of their publication in WHO Drug Information, i.e., for List 125 of Proposed INN not later than 29 November 2021. Publication date: 30/07/2021 Dénominations communes internationales proposées: Liste 125 Des observations ou des objections formelles à l'égard des dénominations proposées peuvent être adressées par toute personne au Programme des Dénominations communes internationales de l'Organisation mondiale de la Santé dans un délai de quatre mois à compter de la date de leur publication dans WHO Drug Information, c'est à dire pour la Liste 125 de DCI Proposées le 29 novembre 2021 au plus tard. Date de publication : 30/07/2021 Denominaciones Comunes Internacionales Propuestas: Lista 125 Cualquier persona puede dirigir observaciones u objeciones respecto de las denominaciones propuestas, al Programa de Comunes Internacionales de la Organización Mundial de la Salud, en un plazo de cuatro meses, contados desde la fecha de su publicación en WHO Drug Information, es decir, para la Lista 125 de DCI Propuestas el 29 de noviembre de 2021 a más tardar. Fecha de publicación: 30/07/2021 Proposed INN Chemical name or description: Action and use: Molecular (Latin, English, French, Spanish) formula Chemical Abstracts Service (CAS) registry number: Graphic formula DCI Proposée Nom chimique ou description: Propriétés et indications: Formule brute Numéro dans le registre du CAS: Formule développée DCI Propuesta Nombre químico o descripción: Acción y uso: Fórmula molecular Número de registro del CAS: Fórmula desarrollada acmucabtagenum autoleucelum # acmucabtagene autoleucel autologous T cells obtained from peripheral blood mononuclear cells by leukapheresis, transduced with a self- inactivating, non-replicating lentiviral vector, encoding a chimeric antigen receptor (CAR) targeting B-lymphocyte antigen CD19 (also known as B-Lymphocyte surface antigen B4) under control of the murine stem cell virus promoter. The transgene is a T cell antigen coupler (TAC) which has three components: 362 WHO Drug Information, Vol. 35, No. 2, 2021 Proposed INN: List 125 (i) an extracellular antigen-binding domain (anti-human CD19; FMC63 single chain variable fragment (scFv)), (ii) an extracellular T cell receptor (TCR) recruitment domain (anti- human CD3ε; UCHT1 scFv [Y177T]), and (iii) a membrane- anchoring co-receptor domain that consists of the transmembrane and cytoplasmic domains of CD4. The vector genome is flanked by 5' and 3' long terminal repeats (LTRs) and contains also a ψ packaging signal, a Rev response element (RRE), a central polypurine tract (cPPT) sequence and the Woodchuck hepatitis virus post-transcriptional regulatory element (WPRE). The leukapheresis material is enriched for CD4/CD8 T cells by positive immunoselection. T cells are cultured in the presence serum-free medium containing IL-2 and IL-7, and activated using a CD3/CD28/CD2 soluble activator. The T cells (>70%, generally ≥99%) are predominantly CD4 and CD8 T cells, with >10% viable CD3+TAC+ cells. cell-based gene therapy (antineoplastic) acmucabtagène autoleucel lymphocytes T autologues obtenus à partir de cellules mononucléaires de sang périphérique par leucaphérèse, transduits avec un vecteur lentiviral auto-inactivant, non répliquant, codant un récepteur antigénique chimérique (CAR) ciblant l'antigène des lymphocytes B CD19 (également connu comme antigène de surface des lymphocytes B B4) sous le contrôle du promoteur du virus des cellules souches murines. Le transgène est un coupleur d'antigène de lymphocyte T (TAC) qui a trois composants: (i) un domaine extracellulaire de liaison à l'antigène (anti-CD19 humain; fragment variable à chaîne unique (scFv) FMC63), (ii) un domaine extracellulaire de recrutement du récepteur des lymphocytes T (TCR) (anti-CD3ε humain; UCHT1 scFv [Y177T]), et (iii) un domaine de corécepteur d'ancrage à la membrane, constitué des domaines transmembranaires et cytoplasmiques du CD4. Le génome du vecteur est flanqué de longues répétitions terminales (LTRs) en 5' et 3' et contient également un signal d'encapsidation ψ, un élément de réponse Rev (RRE), une séquence du tractus polypurine central (cPPT) et l'élément régulateur post-transcriptionnel du virus de l'hépatite de Woodchuck (WPRE). Le matériel de leucaphérèse est enrichi en lymphocytes T CD4/CD8 par immunosélection positive. Les lymphocytes T sont cultivés en présence de milieu sans sérum contenant de l'IL-2 et de l'IL-7, et activés à l'aide d'un activateur soluble CD3/CD28/CD2. Les lymphocytes T (>70%, généralement ≥99%) sont principalement des lymphocytes T CD4 et CD8, avec >10% de cellules CD3+TAC+ viables. thérapie génique à base de cellules (antinéoplasique) acmucabtagén autoleucel linfocitos T autólogos obtenidos a partir de células mononucleares de sangre periférica mediante leucaféresis, transducidos con un vector lentiviral auto inactivante, no replicativo, que codifica para un receptor de antígenos quimérico (CAR) dirigido al antígeno de linfocitos CD19 (también conocido como antígeno de superficie de linfocitos B, B4) bajo el control del promotor del virus de células madre murino. El transgen es un acoplador de antígeno de linfocitos T (TAC) que tiene tres componentes: (i) un dominio extracelular de unión a antígeno (anti-CD19 humano; fragmento de cadena variable sencilla (scFV)
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