{"id":545,"date":"2024-09-05T18:19:55","date_gmt":"2024-09-05T10:19:55","guid":{"rendered":"https:\/\/flcube.com\/?p=545"},"modified":"2024-10-13T17:49:10","modified_gmt":"2024-10-13T09:49:10","slug":"roches-columvi-for-relapsed-dlbcl-gets-review-nod-from-chinas-cde-for-new-indication","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=545","title":{"rendered":"Roche&#8217;s Columvi for Relapsed DLBCL Gets Review Nod from China&#8217;s CDE for New Indication"},"content":{"rendered":"\n<p>The Center for Drug Evaluation (CDE) in China has accepted for review an additional indication approval filing submitted by Swiss pharmaceutical giant Roche (<a href=\"https:\/\/www.google.com\/finance\/quote\/ROG:SWX\">SWX: ROG<\/a>) for its drug Columvi (glofitamab). The filing suggests a potential use in combination with gemcitabine and oxaliplatin for the treatment of diffuse large B-cell lymphoma (DLBCL) in patients who have received prior treatment and are not eligible for autologous stem cell transplantation, as informed by recent clinical trials.<\/p>\n\n\n\n<p>Columvi, a bispecific antibody designed to target both CD20 and CD3, received its initial approval in China in November of the previous year. It was granted for the treatment of recurrent or refractory DLBCL in patients who had already undergone at least two lines of systemic treatment.- <a href=\"https:\/\/flcube.com\">Flcube.com<\/a><\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Center for Drug Evaluation (CDE) in China has accepted for review an additional indication&#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":[38,163,939],"class_list":["post-545","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-market-approval-filings","tag-roche","tag-swx-rop"],"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 Columvi for Relapsed DLBCL Gets Review Nod from China&#039;s CDE for New Indication - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"The Center for Drug Evaluation (CDE) in China has accepted for review an additional indication approval filing submitted by Swiss pharmaceutical giant Roche for its drug Columvi (glofitamab). The filing suggests a potential use in combination with gemcitabine and oxaliplatin for the treatment of diffuse large B-cell lymphoma (DLBCL) in patients who have received prior treatment and are not eligible for autologous stem cell transplantation, as informed by recent clinical trials.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/flcube.com\/?p=545\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Roche&#039;s Columvi for Relapsed DLBCL Gets Review Nod from China&#039;s CDE for New Indication\" \/>\n<meta property=\"og:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. FLCUBE delivers reliable data, news, and intelligence to broaden your horizons and sharpen your decision-making. 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