{"id":12944,"date":"2024-11-15T16:34:26","date_gmt":"2024-11-15T08:34:26","guid":{"rendered":"https:\/\/flcube.com\/?p=12944"},"modified":"2024-11-15T16:34:29","modified_gmt":"2024-11-15T08:34:29","slug":"sanofis-sarclisa-receives-chmp-recommendation-for-newly-diagnosed-multiple-myeloma","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=12944","title":{"rendered":"Sanofi’s Sarclisa Receives CHMP Recommendation for Newly Diagnosed Multiple Myeloma"},"content":{"rendered":"\n

French pharmaceutical giant Sanofi (NASDAQ: SNY<\/a>) has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are not eligible for autologous stem cell transplant (ASCT).<\/p>\n\n\n\n

Sarclisa’s Global Approval Momentum<\/strong>
Sarclisa, a CD38 monoclonal antibody (mAb), received its first global approval in the US in September of this year for the same indication, marking a significant milestone in the first-line treatment of multiple myeloma. The drug also earned an Orphan Drug Designation (ODD) in the US, highlighting its potential to address rare diseases. To date, Sarclisa has been approved in more than 50 countries\/regions worldwide, expanding access to this innovative therapy for patients.<\/p>\n\n\n\n

Positive Results from the IMROZ Study<\/strong>
The CHMP’s positive opinion is supported by the successful outcomes of the IMROZ study, the world’s first Phase III study to combine a CD38 mAb with the standard-of-care VRd regimen. The study demonstrated that the addition of Sarclisa to VRd significantly prolonged progression-free survival (PFS) in patients with NDMM compared to VRd alone, while maintaining a favorable safety profile. This data underscores the potential of Sarclisa in improving outcomes for patients with newly diagnosed multiple myeloma.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

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

French pharmaceutical giant Sanofi (NASDAQ: SNY) has announced that the Committee for Medicinal Products for…<\/p>\n","protected":false},"author":1,"featured_media":12945,"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":[16,38,867,147],"class_list":["post-12944","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-cancer","tag-market-approval-filings","tag-nasdaq-sny","tag-sanofi"],"yoast_head":"\nSanofi's Sarclisa Receives CHMP Recommendation for Newly Diagnosed Multiple Myeloma - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"French pharmaceutical giant Sanofi (NASDAQ: SNY) has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are not eligible for autologous stem cell transplant (ASCT).\" \/>\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=12944\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Sanofi's Sarclisa Receives CHMP Recommendation for Newly Diagnosed Multiple Myeloma\" \/>\n<meta property=\"og:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. 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