{"id":42179,"date":"2023-08-18T07:00:00","date_gmt":"2023-08-18T07:00:00","guid":{"rendered":"http:\/\/93d0f41377edaedd5d1f09f1e265644d"},"modified":"2024-11-03T15:12:24","modified_gmt":"2024-11-03T15:12:24","slug":"fda-approves-trifluridine-and-tipiracil-with-bevacizumab-for-previously-treated-metastatic-colorectal-cancer","status":"publish","type":"post","link":"https:\/\/ogkologos.com\/en\/fda-approves-trifluridine-and-tipiracil-with-bevacizumab-for-previously-treated-metastatic-colorectal-cancer\/","title":{"rendered":"FDA Approves Trifluridine and Tipiracil with Bevacizumab for Previously Treated Metastatic Colorectal Cancer"},"content":{"rendered":"<p>On 2 August 2023, the US Food and Drug Administration (FDA) approved trifluridine and tipiracil (LONSURF, Taiho Oncology, Inc.) with bevacizumab, for metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if <em>RAS<\/em> wild-type, an anti-EGFR therapy. FDA had previously approved single-agent LONSURF for this indication in September 2015.<\/p>\n<p>Full prescribing information for LONSURF is available <a href=\"https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2023\/207981s012lbl.pdf\" target=\"_blank\" rel=\"noopener noreferrer\" class=\"external-link\">here<\/a>.<\/p>\n<p>Safety and efficacy were evaluated in SUNLIGHT (NCT04737187), a randomised, open-label, multicentre, global study of LONSURF with bevacizumab compared to single-agent LONSURF in 492 patients with mCRC who received a maximum of two prior chemotherapy regimens and demonstrated progressive disease or intolerance to the last regimen.<\/p>\n<p>The primary efficacy outcome measures were overall survival (OS) and progression-free survival (PFS). The study demonstrated a statistically significant OS improvement in patients randomised to the LONSURF plus bevacizumab arm compared to those randomised to LONSURF (hazard ratio [HR] 0.61; 95% confidence interval [CI] 0.49, 0.77; 1-sided p &lt; 0.001). Median OS was 10.8 months in the LONSURF plus bevacizumab arm (95% CI 9.4, 11.8) and 7.5 months in the LONSURF arm (95% CI 6.3, 8.6). Median PFS was 5.6 months in the LONSURF plus bevacizumab arm (95% CI 4.5, 5.9) and 2.4 months in the LONSURF arm (95% CI 2.1, 3.2), (HR 0.44; 95% CI 0.36, 0.54; 1-sided p &lt; 0.001).<\/p>\n<p>The most common adverse reactions or laboratory abnormalities for LONSURF with bevacizumab (\u2265 20%) are neutropenia, anaemia, thrombocytopenia, fatigue, nausea, increased AST, increased ALT, increased alkaline phosphatase, decreased sodium, diarrhoea, abdominal pain, and decreased appetite.<\/p>\n<p>The recommended LONSURF dose is 35 mg\/m<sup>2<\/sup> orally twice daily with food on days 1 through 5 and days 8 through 12 of each 28-day cycle. Refer to the Prescribing Information for bevacizumab dosing information.<\/p>\n<p>This application was granted priority review 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-trifluridine-and-tipiracil-with-bevacizumab-for-previously-treated-metastatic-colorectal-cancer\">Source<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>On 2 August 2023, the US Food and Drug Administration (FDA) approved trifluridine and tipiracil (LONSURF, Taiho Oncology, Inc.) with bevacizumab, for metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. FDA had previously approved single-agent LONSURF for this indication in [&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-42179","post","type-post","status-publish","format-standard","hentry","category-world-news"],"_links":{"self":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/42179","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=42179"}],"version-history":[{"count":1,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/42179\/revisions"}],"predecessor-version":[{"id":42861,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/42179\/revisions\/42861"}],"wp:attachment":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/media?parent=42179"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/categories?post=42179"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/tags?post=42179"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}