{"id":191241,"date":"2025-12-18T12:28:00","date_gmt":"2025-12-18T11:28:00","guid":{"rendered":"https:\/\/helloproject.es\/vigilancia\/espana-autoriza-el-primer-ensayo-de-un-farmaco-oncologico-innovador-de-forma-acelerada\/"},"modified":"2025-12-18T12:28:00","modified_gmt":"2025-12-18T11:28:00","slug":"espana-autoriza-el-primer-ensayo-de-un-farmaco-oncologico-innovador-de-forma-acelerada","status":"publish","type":"post","link":"https:\/\/helloproject.es\/vigilancia\/espana-autoriza-el-primer-ensayo-de-un-farmaco-oncologico-innovador-de-forma-acelerada\/","title":{"rendered":"Espa\u00f1a autoriza el primer ensayo de un f\u00e1rmaco oncol\u00f3gico innovador de forma acelerada"},"content":{"rendered":"

La Agencia Espa\u00f1ola de Medicamentos y Productos Sanitarios (Aemps) ha autorizado el primer ensayo cl\u00ednico en fase I de un f\u00e1rmaco innovador para el c\u00e1ncer y enfermedades raras mediante el nuevo procedimiento acelerado o fast track, gracias al cual se ha reducido el proceso regulatorio de 100 a 60 d\u00edas.<\/p>\n

Se trata del estudio Embold, promovido por GSK, en el que se evaluar\u00e1 un f\u00e1rmaco oncol\u00f3gico en investigaci\u00f3n en pacientes con tumores s\u00f3lidos avanzados, seg\u00fan ha informado Farmaindustria en una nota de prensa.<\/p>\n

Se trata del estudio Embold de GSK, en el que se evaluar\u00e1 un f\u00e1rmaco oncol\u00f3gico en investigaci\u00f3n en pacientes con tumores s\u00f3lidos avanzados<\/p>\n

La autorizaci\u00f3n llega un a\u00f1o despu\u00e9s del primer ensayo piloto fast track autorizado por la agencia dependiente del Ministerio de Sanidad, una vacuna tambi\u00e9n desarrollada por GSK.<\/p>\n

<\/a><\/p>\n

Terapias novedosas<\/h2>\n

Con este paso se consolida el nuevo marco regulatorio que busca agilizar el desarrollo de terapias innovadoras en fases tempranas, lo que ha permitido completar el procedimiento regulatorio de este ensayo cl\u00ednico en solo 60 d\u00edas frente a los 100 habituales.<\/p>\n

Desde la presentaci\u00f3n en CTIS (Clinical Trial Information System), realizada el 22 de septiembre pasado, hasta la autorizaci\u00f3n final, el proceso ha avanzado de forma \u00e1gil gracias a la colaboraci\u00f3n entre la Aemps, investigadores, instituciones, Farmaindustria y GSK.<\/p>\n

El estudio Embold fase I\/II evaluar\u00e1 la seguridad, tolerabilidad, farmacocin\u00e9tica y actividad cl\u00ednica de un nuevo compuesto en combinaci\u00f3n con el tratamiento de referencia u otros agentes en pacientes con tumores s\u00f3lidos avanzados.<\/p>\n

Evaluar\u00e1 la seguridad, tolerabilidad, farmacocin\u00e9tica y actividad cl\u00ednica de un nuevo compuesto en combinaci\u00f3n con el tratamiento de referencia\u00a0<\/p>\n

Los primeros pacientes participan ya en el ensayo, que se desarrolla en cinco centros de referencia en oncolog\u00eda en tres comunidades aut\u00f3nomas: el Hospital Universitario Vall d\u2019Hebron (UITM-CaixaResearch), de Barcelona; la Fundaci\u00f3n Jim\u00e9nez D\u00edaz, el Hospital Universitario HM Sanchinarro y el Ram\u00f3n y Cajal, en Madrid; y el Virgen de la Victoria, en M\u00e1laga.<\/p>\n

<\/a><\/p>\n

Una demanda hist\u00f3rica<\/h2>\n

Farmaindustria ha acogido \u201ccon gran satisfacci\u00f3n\u201d la ampliaci\u00f3n del procedimiento a todos los ensayos nacionales en oncolog\u00eda o enfermedades raras de fase I, una demanda hist\u00f3rica tanto de investigadores, industria y pacientes, porque este tipo de medidas \u201cson bienvenidas para\u00a0afianzar el liderazgo espa\u00f1ol en ensayos cl\u00ednicos\u201d.<\/p>\n

En 2024 la Aemps autoriz\u00f3 930 ensayos cl\u00ednicos, lo que coloc\u00f3 a Espa\u00f1a en cabeza en Europa, por delante de pa\u00edses como Francia o Alemania.<\/p>","protected":false},"excerpt":{"rendered":"

La Agencia Espa\u00f1ola de Medicamentos y Productos Sanitarios (Aemps) ha autorizado el primer ensayo cl\u00ednico en fase I de un f\u00e1rmaco innovador para el c\u00e1ncer y enfermedades raras mediante el nuevo procedimiento acelerado o fast track, gracias al cual se ha reducido el proceso regulatorio de 100 a 60 d\u00edas. Se trata del estudio Embold, […]<\/p>\n","protected":false},"author":5,"featured_media":0,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[5],"tags":[],"class_list":["post-191241","post","type-post","status-publish","format-standard","hentry","category-noticias"],"yoast_head":"\nEspa\u00f1a autoriza el primer ensayo de un f\u00e1rmaco oncol\u00f3gico innovador de forma acelerada - bip4ex<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/helloproject.es\/vigilancia\/espana-autoriza-el-primer-ensayo-de-un-farmaco-oncologico-innovador-de-forma-acelerada\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Espa\u00f1a autoriza el primer ensayo de un f\u00e1rmaco oncol\u00f3gico innovador de forma acelerada\" \/>\n<meta property=\"og:description\" content=\"La Agencia Espa\u00f1ola de Medicamentos y Productos Sanitarios (Aemps) ha autorizado el primer ensayo cl\u00ednico en fase I de un f\u00e1rmaco innovador para el c\u00e1ncer y enfermedades raras mediante el nuevo procedimiento acelerado o fast track, gracias al cual se ha reducido el proceso regulatorio de 100 a 60 d\u00edas. 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