{"id":3060,"date":"2023-11-12T23:16:36","date_gmt":"2023-11-12T23:16:36","guid":{"rendered":"http:\/\/drhimanshuyadav.com\/takeda-receives-fda-approval-for-fruquintinib-for-certain-colorectal-cancer-patients\/"},"modified":"2023-11-12T23:16:36","modified_gmt":"2023-11-12T23:16:36","slug":"takeda-receives-fda-approval-for-fruquintinib-for-certain-colorectal-cancer-patients","status":"publish","type":"post","link":"https:\/\/drhimanshuyadav.com\/blog\/takeda-receives-fda-approval-for-fruquintinib-for-certain-colorectal-cancer-patients\/","title":{"rendered":"Takeda receives FDA approval for fruquintinib for certain colorectal cancer patients"},"content":{"rendered":"
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\"Takeda_iStock\/JHVEPhoto\"<\/p>\n

Photo: Takeda sign outside the California office\/iStock; JHVE Photo<\/a><\/em><\/p>\n

The FDA on Wednesday approved Takeda Pharmaceutical’s fruquintinib for adult patients with previously treated metastatic colorectal cancer. Oral targeted therapy for VEGF-1, -2, and -3 receptors carries the brand name Furuzakura.<\/p>\n

Full Sakura-san label<\/a> Patients previously treated with fluoropyrimidine, oxaliplatin, irinotecan chemotherapy, and anti-VEGF agents are eligible. In wild-type RAS metastatic colorectal cancer (mCRC), this therapy is also indicated for patients who have previously received anti-EGFR therapy, if medically appropriate.<\/p>\n

Wednesday’s approval comes more than 20 days before the planned target action date, and Takeda said in a statement that Fluzakura is “approved in the U.S. for previously treated mCRC, regardless of biomarker status.” “The first and only selective inhibitor of all three VEGF receptor kinases”.<\/p>\n

\u201cFluzakura is the first new chemotherapy-free treatment option approved for patients in the United States in more than a decade, regardless of biomarker status,\u201d said Takeda, President of Global Oncology Business Unit. Teresa Vitetti said in a statement. “Furuzakura has the potential to provide significant survival benefits without negatively impacting patients’ quality of life.”<\/p>\n

Furuzakura is an oral inhibitor of VEGF-1, -2, and -3 receptors, which together play an important role in the formation of blood vessels that sustain tumors, and is effective for sustained inhibition while minimizing off-target effects. , with strong selectivity allowing for high doses. of that target.<\/p>\n

FDA approval is based on data from the Phase III FRESCO-2 and FRESCO studies. fresco-2<\/a>a multiregional, randomized, double-blind, placebo-controlled study, showed significantly better survival for patients treated with Fluzacra. fresco<\/a>a similar study conducted in China similarly demonstrated excellent overall survival and progression-free survival after FRUZACRA treatment.<\/p>\n

Fluzakura does not come with a warning on the box, but it does list precautions against high blood pressure, infections, liver toxicity, bleeding events, and other potential side effects.<\/p>\n

Wednesday’s regulatory victory ends a losing streak for Takeda, which has suffered both clinical and court defeats in recent months.<\/p>\n

In September 2023, the U.S. Court of Appeals ruled that Genentech’s hemophilia A drug Hemlibra (emicizumab) did not infringe protections held by Takeda subsidiary Baxalta, leading to Takeda’s patent lawsuit with Roche. Lost the case.<\/p>\n

Last month, the company was forced to withdraw its lung cancer drug Exquivity (mobocertinib) from the U.S. and global markets after it failed to meet its primary endpoint in a confirmatory Phase III trial.<\/p>\n

Additionally, in its recent third-quarter earnings report, Takeda took more than $770 million in writedowns and lowered its fiscal 2023 outlook by 71%.<\/p>\n

Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Please contact tristan@tristanmanalac.com or tristan.manalac@biospace.com.<\/em><\/p>\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"

Photo: Takeda sign outside the California office\/iStock; JHVE Photo The FDA on Wednesday approved Takeda Pharmaceutical’s fruquintinib for adult patients with previously treated metastatic colorectal cancer. Oral targeted therapy for VEGF-1, -2, and -3 receptors carries the brand name Furuzakura. Full Sakura-san label Patients previously treated with fluoropyrimidine, oxaliplatin, irinotecan chemotherapy, and anti-VEGF agents are … Read more<\/a><\/p>\n","protected":false},"author":2,"featured_media":3061,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[5],"tags":[704,3,24,705,731,11,714,715],"class_list":["post-3060","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-colorectal-cancer","tag-approval","tag-cancer","tag-colorectal","tag-fda","tag-fruquintinib","tag-patients","tag-receives","tag-takeda"],"_links":{"self":[{"href":"https:\/\/drhimanshuyadav.com\/blog\/wp-json\/wp\/v2\/posts\/3060","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/drhimanshuyadav.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/drhimanshuyadav.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/drhimanshuyadav.com\/blog\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/drhimanshuyadav.com\/blog\/wp-json\/wp\/v2\/comments?post=3060"}],"version-history":[{"count":0,"href":"https:\/\/drhimanshuyadav.com\/blog\/wp-json\/wp\/v2\/posts\/3060\/revisions"}],"wp:attachment":[{"href":"https:\/\/drhimanshuyadav.com\/blog\/wp-json\/wp\/v2\/media?parent=3060"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/drhimanshuyadav.com\/blog\/wp-json\/wp\/v2\/categories?post=3060"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/drhimanshuyadav.com\/blog\/wp-json\/wp\/v2\/tags?post=3060"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}