{"id":13649,"date":"2023-09-20T00:49:00","date_gmt":"2023-09-19T16:49:00","guid":{"rendered":"https:\/\/flcube.com\/?p=13649"},"modified":"2024-11-20T00:52:04","modified_gmt":"2024-11-19T16:52:04","slug":"astellas-pharmas-xtandi-nda-for-mhspc-treatment-accepted-by-chinas-cde","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=13649","title":{"rendered":"Astellas Pharma&#8217;s Xtandi NDA for mHSPC Treatment Accepted by China&#8217;s CDE"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">Japan-based Astellas Pharma Inc. (<a href=\"https:\/\/www.google.com\/finance\/quote\/4503:TYO\">TYO: 4503<\/a>) has announced that the Center for Drug Evaluation (CDE) has accepted for review the New Drug Application (NDA) for its medication Xtandi (enzalutamide), which is intended for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC).<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>NDA Basis and Study Results<\/strong><br>The NDA is supported by the outcomes of the Phase III China ARCHES study. The study involved 180 Chinese patients with mHSPC in mainland China, who were randomized to receive Xtandi in combination with androgen deprivation therapy (ADT) or a placebo plus ADT. The study successfully met its primary endpoint, showing a statistically significant improvement in time to prostate-specific antigen (PSA) progression (TTPP). This progression is defined as a \u2265 25% increase and an absolute increase of \u2265 2 \u00b5g\/L (2 ng\/mL) above the nadir PSA value, confirmed by a second consecutive value at least 3 weeks later. These results are consistent with those from Astellas\u2019 global Phase III ARCHES study, which targeted the same patient population.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Prostate Cancer in China and Urgent Need for Treatment<\/strong><br>Prostate cancer is the most prevalent cancer among the male urogenital system in China, with an increasing incidence. The median survival period for Chinese patients with metastatic hormone-sensitive prostate cancer after receiving androgen deprivation treatment is only 3-4 years, highlighting the urgent need for new treatment options.<a href=\"https:\/\/flcube.com\">-Fineline Info &amp; Tech<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Japan-based Astellas Pharma Inc. (TYO: 4503) has announced that the Center for Drug Evaluation (CDE)&#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":[353,16,38,1177],"class_list":["post-13649","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-astellas-pharma","tag-cancer","tag-market-approval-filings","tag-tyo-4503"],"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>Astellas Pharma&#039;s Xtandi NDA for mHSPC Treatment Accepted by China&#039;s CDE - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Japan-based Astellas Pharma Inc. 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