{"id":46525,"date":"2024-02-20T08:00:00","date_gmt":"2024-02-20T08:00:00","guid":{"rendered":"http:\/\/17723bbb53463d7c70c7bcb64a5d9c83"},"modified":"2024-11-03T15:11:53","modified_gmt":"2024-11-03T15:11:53","slug":"fda-approves-tepotinib-for-metastatic-non-small-cell-lung-cancer","status":"publish","type":"post","link":"https:\/\/ogkologos.com\/en\/fda-approves-tepotinib-for-metastatic-non-small-cell-lung-cancer\/","title":{"rendered":"FDA Approves Tepotinib for Metastatic Non-Small Cell Lung Cancer"},"content":{"rendered":"<p>On 15 February 2024, the US Food and Drug Administration (FDA) granted traditional approval to tepotinib (Tepmetko, EMD Serono, Inc.) for adult patients with metastatic non-small cell lung cancer (NSCLC) harbouring mesenchymal-epithelial transition (<em>MET<\/em>) exon 14 skipping alterations.<\/p>\n<p>Tepotinib was previously granted accelerated approval for this indication on 3rd February 2021, based on initial overall response rate (ORR) and duration of response (DoR) in the VISION study (NCT02864992), a multicentre, non-randomised, open-label, multicohort study. The conversion to traditional approval was based on an additional 161 patients and an added 28 months of follow-up time to assess DoR.<\/p>\n<p>Efficacy was demonstrated in a total of 313 patients with metastatic NSCLC harbouring <em>MET <\/em>exon skipping alterations. Patients received tepotinib 450 mg once daily until disease progression or unacceptable toxicity.<\/p>\n<p>The primary efficacy measures were ORR and DoR, determined by a Blinded Independent Review Committee. Among 164 treatment-na\u00efve patients, ORR was 57% (95% confidence interval [CI] 49, 65), with 40% of responders having a DoR \u226512 months. Among 149 previously treated patients, ORR was 45% (95% CI 37, 53), with 36% of responders having a DoR \u226512 months.<\/p>\n<p>The most common adverse reactions (\u226520%) were oedema, nausea, fatigue, musculoskeletal pain, diarrhoea, dyspnoea, decreased appetite, and rash.<\/p>\n<p>The recommended tepotinib dose is 450 mg orally once daily with food.<\/p>\n<p>This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA\u2019s assessment.<\/p>\n<p>This application was granted breakthrough designation and orphan drug designation.<\/p>\n<p>Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA\u2019s MedWatch Reporting System.<\/p>\n<p>For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact FDA\u2019s <a href=\"https:\/\/www.fda.gov\/about-fda\/fda-organization\/oncology-center-excellence\" target=\"_blank\" rel=\"noopener noreferrer\" class=\"external-link\">Oncology Center of Excellence<\/a>&nbsp;<a href=\"https:\/\/www.fda.gov\/about-fda\/oncology-center-excellence\/project-facilitate\" target=\"_blank\" rel=\"noopener noreferrer\" class=\"external-link\">Project Facilitate<\/a>.<\/p>\n<p><a href=\"https:\/\/www.esmo.org\/oncology-news\/fda-approves-tepotinib-for-metastatic-non-small-cell-lung-cancer\">Source<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>On 15 February 2024, the US Food and Drug Administration (FDA) granted traditional approval to tepotinib (Tepmetko, EMD Serono, Inc.) for adult patients with metastatic non-small cell lung cancer (NSCLC) harbouring mesenchymal-epithelial transition (MET) exon 14 skipping alterations. Tepotinib was previously granted accelerated approval for this indication on 3rd February 2021, based on initial overall [&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-46525","post","type-post","status-publish","format-standard","hentry","category-world-news"],"_links":{"self":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/46525","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=46525"}],"version-history":[{"count":1,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/46525\/revisions"}],"predecessor-version":[{"id":47117,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/46525\/revisions\/47117"}],"wp:attachment":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/media?parent=46525"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/categories?post=46525"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/tags?post=46525"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}