{"id":46715,"date":"2024-07-26T07:00:00","date_gmt":"2024-07-26T07:00:00","guid":{"rendered":"http:\/\/b6ecdcae133cb2244706f74a67de32d0"},"modified":"2024-11-03T15:11:48","modified_gmt":"2024-11-03T15:11:48","slug":"ema-recommends-to-extend-therapeutic-indications-for-crizotinib-in-paediatric-patients","status":"publish","type":"post","link":"https:\/\/ogkologos.com\/en\/ema-recommends-to-extend-therapeutic-indications-for-crizotinib-in-paediatric-patients\/","title":{"rendered":"EMA Recommends to Extend Therapeutic Indications for Crizotinib in Paediatric Patients"},"content":{"rendered":"<p>On 27 June 2024, the European Medicines Agency\u2019s (EMA\u2019s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product crizotinib (Xalkori).<\/p>\n<p>The marketing authorisation holder for this medicinal product is Pfizer Europe MA EEIG.<\/p>\n<p>The CHMP adopted an extension to existing indications in anaplastic lymphoma kinase (<em>ALK<\/em>)-positive anaplastic large cell lymphoma (ALCL) and unresectable inflammatory myofibroblastic tumour (IMT) to include treatment of children from 1 year of age. Previously, it was recommended for paediatric patients who are at least 16 years old.<\/p>\n<p>For information, the full indication will be as follows:<\/p>\n<p>Xalkori as monotherapy is indicated for:<\/p>\n<ul>\n<li>The first-line treatment of adults with <em>ALK<\/em>-positive advanced non-small cell lung cancer (NSCLC)&nbsp;<\/li>\n<li>The treatment of adults with previously treated <em>ALK<\/em>-positive advanced NSCLC<\/li>\n<li>The treatment of adults with <em>ROS1<\/em>-positive advanced NSCLC<\/li>\n<li>The treatment of paediatric patients (age \u22651 to &lt;18 years) with relapsed or refractory systemic <em>ALK<\/em>-positive anaplastic large cell lymphoma<\/li>\n<li>The treatment of paediatric patients (age \u22651 to &lt;18 years) with recurrent or refractory <em>ALK<\/em>-positive unresectable inflammatory myofibroblastic tumour.<\/li>\n<\/ul>\n<p>Detailed recommendations for the use of this product will be described in the updated summary of product characteristics, which will be published in the revised European public assessment report, and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.<\/p>\n<p>Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion.<\/p>\n<p><a href=\"https:\/\/www.esmo.org\/oncology-news\/ema-recommends-to-extend-therapeutic-indications-for-crizotinib-in-paediatric-patients\">Source<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>On 27 June 2024, the European Medicines Agency\u2019s (EMA\u2019s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product crizotinib (Xalkori). The marketing authorisation holder for this medicinal product is Pfizer Europe MA EEIG. The CHMP adopted an extension [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"footnotes":""},"categories":[5137],"tags":[],"class_list":["post-46715","post","type-post","status-publish","format-standard","hentry","category-world-news"],"_links":{"self":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/46715","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/comments?post=46715"}],"version-history":[{"count":1,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/46715\/revisions"}],"predecessor-version":[{"id":46959,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/46715\/revisions\/46959"}],"wp:attachment":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/media?parent=46715"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/categories?post=46715"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/tags?post=46715"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}