{"id":46303,"date":"2023-10-16T07:00:00","date_gmt":"2023-10-16T07:00:00","guid":{"rendered":"http:\/\/465e313e3068703a87eac64959a62559"},"modified":"2024-11-03T15:12:22","modified_gmt":"2024-11-03T15:12:22","slug":"fda-approves-encorafenib-with-binimetinib-for-metastatic-non-small-cell-lung-cancer-with-a-braf-v600e-mutation","status":"publish","type":"post","link":"https:\/\/ogkologos.com\/en\/fda-approves-encorafenib-with-binimetinib-for-metastatic-non-small-cell-lung-cancer-with-a-braf-v600e-mutation\/","title":{"rendered":"FDA Approves Encorafenib with Binimetinib for Metastatic Non-Small Cell Lung Cancer with a BRAF V600E Mutation"},"content":{"rendered":"<p>On 11 October 2023, the US Food and Drug Administration (FDA) approved encorafenib (Braftovi, Array BioPharma Inc., a wholly owned subsidiary of Pfizer) with binimetinib (Mektovi, Array BioPharma Inc.) for adult patients with metastatic non-small cell lung cancer (NSCLC) with a <em>BRAF<\/em> V600E mutation, as detected by an FDA-approved test.<\/p>\n<p>FDA also approved the FoundationOne CDx (tissue) and FoundationOne Liquid CDx (plasma) as companion diagnostics for encorafenib with binimetinib. If no mutation is detected in a plasma specimen, the tumour tissue should be tested.<\/p>\n<p>Full prescribing information for Braftovi and Mektovi is available <a href=\"https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2023\/210496s014lbl.pdf\" target=\"_blank\" rel=\"noopener noreferrer\" class=\"external-link\">here<\/a>.&nbsp;<\/p>\n<p>Efficacy was evaluated in 98 patients with metastatic NSCLC with <em>BRAF<\/em> V600E mutation enrolled in PHAROS (NCT03915951), an open-label, multicentre, single-arm study. Prior BRAF or MEK inhibitors was not allowed. Patients received encorafenib and binimetinib until disease progression or unacceptable toxicity.<\/p>\n<p>The major efficacy outcome measures were objective response rate (ORR) per RECIST v1.1 and duration of response (DoR), as assessed by an independent review committee. Among 59 treatment-na\u00efve patients, ORR was 75% (95% confidence interval [CI] 62, 85); median DoR was not estimable (NE) (95% CI 23.1, NE). Among 39 previously treated patients, ORR was 46% (95% CI 30, 63) with a median DoR of 16.7 months (95% CI 7.4, NE).<\/p>\n<p>The most common adverse reactions (\u226525%) were fatigue, nausea, diarrhoea, musculoskeletal pain, vomiting, abdominal pain, visual impairment, constipation, dyspnoea, rash, and cough.<\/p>\n<p>The recommended doses for <em>BRAF<\/em> V600E mutation-positive NSCLC are encorafenib 450 mg orally once daily and binimetinib 45 mg orally twice daily.<\/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 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&nbsp;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> <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-encorafenib-with-binimetinib-for-metastatic-non-small-cell-lung-cancer-with-a-braf-v600e-mutation\">Source<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>On 11 October 2023, the US Food and Drug Administration (FDA) approved encorafenib (Braftovi, Array BioPharma Inc., a wholly owned subsidiary of Pfizer) with binimetinib (Mektovi, Array BioPharma Inc.) for adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. FDA also approved the FoundationOne [&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":[1],"tags":[],"class_list":["post-46303","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/46303","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=46303"}],"version-history":[{"count":1,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/46303\/revisions"}],"predecessor-version":[{"id":47172,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/46303\/revisions\/47172"}],"wp:attachment":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/media?parent=46303"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/categories?post=46303"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/tags?post=46303"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}