{"id":7536,"date":"2024-03-21T23:22:00","date_gmt":"2024-03-21T15:22:00","guid":{"rendered":"https:\/\/flcube.com\/?p=7536"},"modified":"2024-10-17T23:25:19","modified_gmt":"2024-10-17T15:25:19","slug":"fda-grants-accelerated-approval-for-takedas-iclusig-in-newly-diagnosed-ph-all","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=7536","title":{"rendered":"FDA Grants Accelerated Approval for Takeda&#8217;s Iclusig in Newly Diagnosed Ph+ ALL"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">The U.S. Food and Drug Administration (FDA) has granted accelerated indication extension approval to Japan&#8217;s Takeda Pharmaceutical Company (<a href=\"https:\/\/www.google.com\/finance\/quote\/4502:TYO\">TYO: 4502<\/a>) for its tyrosine kinase inhibitor (TKI) Iclusig (ponatinib) in combination with chemotherapy for the treatment of newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). This follows the drug&#8217;s previous approvals for T315I-positive Ph+ ALL, Ph+ ALL patients with no kinase inhibitor alternatives, and various chronic myeloid leukemia (CML) indications.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The FDA&#8217;s conditional approval is based on promising early data from a late-stage clinical trial, which successfully met its primary endpoint of achieving a minimal residual disease (MRD)-negative complete remission (CR) rate after three cycles of treatment. Takeda reported that the combination therapy demonstrated over a two-fold improvement in this outcome compared to the standard treatment of TKI imatinib (Novartis&#8217;s Glivec) plus chemotherapy.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Safety profiles between the Iclusig and imatinib treatment arms were found to be comparable, indicating a favorable risk-benefit profile for the new indication.- <a href=\"https:\/\/flcube.com\">Flcube.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The U.S. Food and Drug Administration (FDA) has granted accelerated indication extension approval to Japan&#8217;s&#8230;<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2},"jetpack_post_was_ever_published":false},"categories":[7,11],"tags":[16,15,345,33,1141],"class_list":["post-7536","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-cancer","tag-product-approvals","tag-takeda","tag-tkis-egfr-vegf-btk-etc","tag-tyo-4502"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.5 (Yoast SEO v27.8) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FDA Grants Accelerated Approval for Takeda&#039;s Iclusig in Newly Diagnosed Ph+ ALL - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"The U.S. Food and Drug Administration (FDA) has granted accelerated indication extension approval to Japan&#039;s Takeda Pharmaceutical Company (TYO: 4502) for its tyrosine kinase inhibitor (TKI) Iclusig (ponatinib) in combination with chemotherapy for the treatment of newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). 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