{"id":26899,"date":"2022-08-15T20:49:00","date_gmt":"2022-08-15T12:49:00","guid":{"rendered":"https:\/\/flcube.com\/?p=26899"},"modified":"2025-02-15T20:51:22","modified_gmt":"2025-02-15T12:51:22","slug":"roches-rozlytrek-wins-nmpa-approval-for-ros1-nsclc-treatment","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=26899","title":{"rendered":"Roche&#8217;s Rozlytrek Wins NMPA Approval for ROS1+ NSCLC Treatment"},"content":{"rendered":"\n<p>Swiss pharmaceutical giant Roche&#8217;s China unit announced that it has received market approval from the National Medical Products Administration (NMPA) for its drug Rozlytrek (entrectinib). The approved indication is for the treatment of ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).<\/p>\n\n\n\n<p><strong>Drug Background<\/strong><br>Entrectinib, the first ROS1 inhibitor with clear central nervous system (CNS) efficacy to become available in China, was initially approved in late July to treat NTRK fusion-positive solid tumors. The second indication approval comes less than two weeks later.<\/p>\n\n\n\n<p><strong>Global Approvals<\/strong><br>Entrectinib, a selective TRK \/ ROS1 inhibitor with CNS activities that can penetrate the blood-brain barrier, has already been approved in Japan, the US, and the European Union for the treatment of NTRK fusion-positive solid tumors and ROS1-positive advanced NSCLC. The drug was first approved in China in July 2022, making it the second NTRK inhibitor in the country following Bayer&#8217;s Vitrakvi (larotrectinib).<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Swiss pharmaceutical giant Roche&#8217;s China unit announced that it has received market approval from the&#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_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}},"categories":[7,11],"tags":[16,15,163,33],"class_list":["post-26899","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-cancer","tag-product-approvals","tag-roche","tag-tkis-egfr-vegf-btk-etc"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Roche&#039;s Rozlytrek Wins NMPA Approval for ROS1+ NSCLC Treatment - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Swiss pharmaceutical giant Roche&#039;s China unit announced that it has received market approval from the National Medical Products Administration (NMPA) for its drug Rozlytrek (entrectinib). 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