{"id":26799,"date":"2021-02-23T13:11:00","date_gmt":"2021-02-23T13:11:00","guid":{"rendered":"http:\/\/5ae3bf5bbe0652467a299560c0a86bd7"},"modified":"2024-11-03T15:15:46","modified_gmt":"2024-11-03T15:15:46","slug":"fda-approves-cemiplimab-rwlc-for-advanced-non-small-cell-lung-cancer-with-high-pd-l1-expression","status":"publish","type":"post","link":"https:\/\/ogkologos.com\/en\/fda-approves-cemiplimab-rwlc-for-advanced-non-small-cell-lung-cancer-with-high-pd-l1-expression\/","title":{"rendered":"FDA Approves Cemiplimab-rwlc for Advanced Non-Small Cell Lung Cancer With High PD-L1 Expression"},"content":{"rendered":"<p>On 22 February 2021, the US Food and Drug Administration (FDA) approved cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals, Inc.) for the first-line treatment of patients with locally advanced non-small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation or metastatic NSCLC whose tumours have high PD-L1 expression (Tumour Proportion Score [TPS]&nbsp;<u>&gt;<\/u>&nbsp;50%) as determined by an FDA-approved test, with no <em>EGFR<\/em>, <em>ALK<\/em> or <em>ROS1<\/em> aberrations.<\/p>\n<p>Efficacy was evaluated in Study 1624 (NCT03088540), a multicentre, randomised, open-label study in 710 patients with locally advanced NSCLC who were not candidates for surgical resection or definitive chemoradiation or with metastatic NSCLC. Patients were randomised (1:1) to receive cemiplimab-rwlc 350 mg intravenously every 3 weeks for up to 108 weeks or a platinum-based chemotherapy. The main efficacy outcome measures were overall survival (OS) and progression-free survival (PFS) per blinded independent central review (BICR).<\/p>\n<p>The study demonstrated statistically significant improvements in OS and PFS for patients receiving cemiplimab-rwlc compared to those treated with platinum-based chemotherapy. Median OS was 22.1 months (95% confidence interval [CI] 17.7, NE) for patients in the cemiplimab-rwlc arm compared with 14.3 months (95% CI 11.7, 19.2) in the chemotherapy arm (HR 0.68; 95% CI 0.53, 0.87, p=0.0022). Median PFS per BICR was 6.2 months (4.5, 8.3) in the cemiplimab-rwlc arm and 5.6 months (4.5, 6.1) in the chemotherapy arm (HR 0.59; 95% CI 0.49, 0.72, p&lt;0.0001). Confirmed overall response rate per BICR was 37% (95% CI 32, 42) and 21% (95% CI 17, 25) in the cemiplimab-rwlc and chemotherapy arms, respectively.<\/p>\n<p>The most common adverse reactions (<u>&gt;<\/u>10%) with cemiplimab-rlwc as a single agent in Study 1624 were musculoskeletal pain, rash, anaemia, fatigue, decreased appetite, pneumonia and cough.<\/p>\n<p>The recommended cemiplimab-rwlc dose for treatment of NSCLC is 350 mg every 3 weeks, intravenously over 30 minutes.<\/p>\n<p>Full prescribing information for Libtayo is available <a href=\"https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/761097s007lbl.pdf\" target=\"_blank\" rel=\"nofollow noopener noreferrer\" class=\"external-link\">here<\/a>.<\/p>\n<p>This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA\u2019s assessment. This application was granted priority review.<\/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=\"nofollow 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=\"nofollow noopener noreferrer\" class=\"external-link\">Project Facilitate<\/a>.<\/p>\n<p><a href=\"http:\/\/www.esmo.org\/oncology-news\/fda-approves-cemiplimab-rwlc-for-advanced-non-small-cell-lung-cancer-with-high-pd-l1-expression\">Source<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>On 22 February 2021, the US Food and Drug Administration (FDA) approved cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals, Inc.) for the first-line treatment of patients with locally advanced non-small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation or metastatic NSCLC whose tumours have high PD-L1 expression (Tumour Proportion Score [TPS]&nbsp;&gt;&nbsp;50%) as [&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-26799","post","type-post","status-publish","format-standard","hentry","category-world-news"],"_links":{"self":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/26799","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=26799"}],"version-history":[{"count":1,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/26799\/revisions"}],"predecessor-version":[{"id":43949,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/26799\/revisions\/43949"}],"wp:attachment":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/media?parent=26799"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/categories?post=26799"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/tags?post=26799"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}