{"id":26461,"date":"2020-10-20T09:00:00","date_gmt":"2020-10-20T09:00:00","guid":{"rendered":"http:\/\/092a22625e07ac7b76d4eef574d56970"},"modified":"2024-11-03T15:16:16","modified_gmt":"2024-11-03T15:16:16","slug":"fda-extends-approval-of-pembrolizumab-for-classical-hodgkin-lymphoma","status":"publish","type":"post","link":"https:\/\/ogkologos.com\/en\/fda-extends-approval-of-pembrolizumab-for-classical-hodgkin-lymphoma\/","title":{"rendered":"FDA Extends Approval of Pembrolizumab for Classical Hodgkin Lymphoma"},"content":{"rendered":"<p>On 14 October 2020, the US Food and Drug Administration (FDA) extended the approval of pembrolizumab (KEYTRUDA<sup>\u00ae<\/sup>, Merck Sharp &amp; Dohme Corp.) for the following indications:<\/p>\n<ul>\n<li>adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL), and<\/li>\n<li>paediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.<\/li>\n<\/ul>\n<p>Approval was based on KEYNOTE-204 (NCT02684292), a phase III, randomised, open-label trial in 304 adult patients with relapsed or refractory cHL after at least one multiagent regimen. Patients were randomised (1:1) to receive either pembrolizumab 200 mg every 3 weeks or brentuximab vedotin (BV) 1.8 mg\/kg every 3 weeks for up to 2 years.<\/p>\n<p>Efficacy was based on progression-free survival (PFS) per blinded independent central review assessment. PFS was statistically significantly longer in the pembrolizumab arm. The median PFS was 13.2 months (95% confidence interval [CI] 10.9, 19.4) in the pembrolizumab arm and 8.3 months (95% CI 5.7, 8.8) in the BV arm, with a hazard ratio of 0.65 (95% CI 0.48, 0.88; p = 0.0027).<\/p>\n<p>Serious adverse reactions occurred in 30% of the patients who received pembrolizumab. Serious adverse reactions in \u22651% of patients included pneumonitis, pneumonia, pyrexia, myocarditis, acute kidney injury, febrile neutropenia, and sepsis.<\/p>\n<p>Adverse reactions in \u226520% of pembrolizumab recipients included upper respiratory tract infection, musculoskeletal pain, diarrhoea, cough, pyrexia, fatigue, and rash. Thirty-eight percent of patients had adverse reactions requiring systemic corticosteroids, including pneumonitis in 11%.<\/p>\n<p>The recommended pembrolizumab dose for patients with lymphoma is 200 mg every 3 weeks or 400 mg every 6 weeks intravenously for adults, or 2 mg\/kg (up to 200 mg) every 3 weeks intravenously for paediatric patients, for up to 2 years.<\/p>\n<p>Full prescribing information for KEYTRUDA<sup>\u00ae<\/sup> is available <a href=\"https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/125514s085lbl.pdf\" target=\"_blank\" rel=\"nofollow noopener noreferrer\" class=\"external-link\">here<\/a>.<\/p>\n<p>The FDA collaborated with the Australian Therapeutics Goods Administration (TGA) and Health Canada (HC) as part of <a href=\"https:\/\/www.fda.gov\/about-fda\/oncology-center-excellence\/project-orbis\" target=\"_blank\" rel=\"nofollow noopener noreferrer\" class=\"external-link\">Project Orbis<\/a>. The review of the application is ongoing for the TGA and HC. 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, breakthrough therapy designation, and 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-extends-approval-of-pembrolizumab-for-classical-hodgkin-lymphoma\">Source<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>On 14 October 2020, the US Food and Drug Administration (FDA) extended the approval of pembrolizumab (KEYTRUDA\u00ae, Merck Sharp &amp; Dohme Corp.) for the following indications: adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL), and paediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy. Approval [&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-26461","post","type-post","status-publish","format-standard","hentry","category-world-news"],"_links":{"self":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/26461","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=26461"}],"version-history":[{"count":1,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/26461\/revisions"}],"predecessor-version":[{"id":46005,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/26461\/revisions\/46005"}],"wp:attachment":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/media?parent=26461"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/categories?post=26461"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/tags?post=26461"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}