{"id":46782,"date":"2024-09-18T09:44:00","date_gmt":"2024-09-18T09:44:00","guid":{"rendered":"http:\/\/08e2135e918a41f4085ec188cefd5c45"},"modified":"2024-11-03T15:11:47","modified_gmt":"2024-11-03T15:11:47","slug":"fda-approves-neoadjuvant-adjuvant-durvalumab-for-patients-with-resectable-nsclc","status":"publish","type":"post","link":"https:\/\/ogkologos.com\/en\/fda-approves-neoadjuvant-adjuvant-durvalumab-for-patients-with-resectable-nsclc\/","title":{"rendered":"FDA Approves Neoadjuvant\/Adjuvant Durvalumab for Patients with Resectable NSCLC"},"content":{"rendered":"<p>On 15 August 2024, the US Food and Drug Administration (FDA) approved durvalumab (Imfinzi, AstraZeneca) with platinum-containing chemotherapy as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment after surgery for adults with resectable (tumours \u2265 4 cm and\/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (<em>EGFR<\/em>) mutations or anaplastic lymphoma kinase (<em>ALK<\/em>) rearrangements.<\/p>\n<p>Efficacy was evaluated in AEGEAN (NCT03800134), a randomised, double-blind, placebo-controlled multicentre study in 802 patients with previously untreated and resectable squamous or non-squamous NSCLC (Stage IIA to select Stage IIIB [AJCC, 8th edition]). Patients were randomised (1:1) to either durvalumab or placebo, with platinum-based chemotherapy, every 3 weeks for up to 4 cycles (neoadjuvant treatment) followed by either continued single-agent durvalumab or placebo, every 4 weeks for up to 12 cycles (adjuvant treatment).<\/p>\n<p>The major efficacy outcome measures were event-free survival (EFS) by blinded independent central review assessment and pathological complete response (pCR) by blinded central pathology review. Median EFS was not reached (95% confidence interval [CI] 31.9, not estimable [NE]) in the durvalumab arm and 25.9 months (95% CI 18.9, NE) in the placebo arm (hazard ratio 0.68, 95% CI 0.53, 0.88; p-value = 0.0039). The pCR rate was 17% (95% CI 13, 21) and 4.3% (95% CI 2.5, 7) in the durvalumab and placebo arms, respectively. &nbsp;At the time of the prespecified interim analyses, overall survival was not formally tested for statistical significance; however, a descriptive analysis revealed no clear detriment.<\/p>\n<p>The most common adverse reactions (\u226520%) were anaemia, nausea, constipation, fatigue, musculoskeletal pain, and rash. Of the patients who received neoadjuvant durvalumab, 1.7% were unable to receive surgery due to adverse reactions compared with 1% in the placebo arm.<\/p>\n<p>For patients with a body weight of \u226530 kg, the recommended durvalumab dosage is 1,500 mg every 3 weeks (neoadjuvant treatment) and every 4 weeks (adjuvant treatment). For patients with a body weight of &lt;30 kg, the recommended durvalumab dosage is 20 mg\/kg. Durvalumab should be administered prior to chemotherapy when administered on the same day.<\/p>\n<p>This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA\u2019s assessment.<\/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-neoadjuvant-adjuvant-durvalumab-for-patients-with-resectable-nsclc\">Source<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>On 15 August 2024, the US Food and Drug Administration (FDA) approved durvalumab (Imfinzi, AstraZeneca) with platinum-containing chemotherapy as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment after surgery for adults with resectable (tumours \u2265 4 cm and\/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations [&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-46782","post","type-post","status-publish","format-standard","hentry","category-world-news"],"_links":{"self":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/46782","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=46782"}],"version-history":[{"count":1,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/46782\/revisions"}],"predecessor-version":[{"id":46905,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/46782\/revisions\/46905"}],"wp:attachment":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/media?parent=46782"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/categories?post=46782"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/tags?post=46782"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}