{"id":12692,"date":"2024-11-14T15:29:29","date_gmt":"2024-11-14T07:29:29","guid":{"rendered":"https:\/\/flcube.com\/?p=12692"},"modified":"2024-11-14T15:29:32","modified_gmt":"2024-11-14T07:29:32","slug":"novartis-pluvicto-accepted-for-review-by-chinas-nmpa-for-prostate-cancer-treatment","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=12692","title":{"rendered":"Novartis’ Pluvicto Accepted for Review by China’s NMPA for Prostate Cancer Treatment"},"content":{"rendered":"\n

The Center for Drug Evaluation (CDE) under China’s National Medical Products Administration (NMPA) has accepted a marketing approval filing from Swiss pharmaceutical giant Novartis (NYSE: NVS<\/a>) for its radioligand therapy (RLT), Pluvicto (177Lu vipivotide tetraxetan). This acceptance marks a significant step towards making this innovative treatment available to patients in China.<\/p>\n\n\n\n

Pluvicto: A Milestone in Prostate Cancer Treatment<\/strong>
Pluvicto, an RLT targeting prostate-specific membrane antigen (PSMA), is recognized as the first RLT approved in the US for treating patients with castration-resistant prostate cancer (CRPC). In September 2024, both 177Lu vipivotide tetraxetan and CDx 68Ga gozetotide were awarded priority review status by the CDE. Pluvicto is indicated for adult patients with PSMA-positive metastatic CRPC who have been previously treated with androgen receptor pathway inhibition and paclitaxel chemotherapy. CDx 68Ga gozetotide is suitable for identifying PSMA-positive lesions in adult prostate cancer patients through PET-CT, enhancing diagnostic accuracy.<\/p>\n\n\n\n

Global Expansion of Novartis’ RLT Capabilities<\/strong>
Novartis continues to strengthen its RLT research and development and manufacturing capabilities, with production bases established in Italy, Spain, the US, and China, among others. The company received approval from the US Food and Drug Administration (FDA) in January to commence commercial manufacturing of Pluvicto at its Indianapolis plant. This facility, Novartis’s largest RLT site to date, enables the company to deliver the drug to patients across the US within 12 hours, highlighting its commitment to rapid and efficient drug distribution.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

The Center for Drug Evaluation (CDE) under China’s National Medical Products Administration (NMPA) has accepted…<\/p>\n","protected":false},"author":1,"featured_media":12693,"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":[16,38,140,865],"class_list":["post-12692","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-cancer","tag-market-approval-filings","tag-novartis","tag-nyse-nvs"],"yoast_head":"\nNovartis' Pluvicto Accepted for Review by China's NMPA for Prostate Cancer Treatment - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"The Center for Drug Evaluation (CDE) under China's National Medical Products Administration (NMPA) has accepted a marketing approval filing from Swiss pharmaceutical giant Novartis (NYSE: NVS) for its radioligand therapy (RLT), Pluvicto (177Lu vipivotide tetraxetan). 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