(IN BRIEF) The CHMP has recommended EU approval of Sarclisa alongside VRd for transplant-eligible NDMM, based on GMMG-HD7 trial results showing superior MRD negativity and PFS compared to VRd alone. This potential label extension would mark Sarclisa’s fourth EU approval … Read the full press release
Posted in France, Healthcare, Pharma & Biotech
Tagged ASH 2024, autologous stem cell transplant, bortezomib, CHMP, dexamethasone, European Medicines Agency, GMMG-HD7, isatuximab, Journal of Clinical Oncology, lenalidomide, MRD negativity, Multiple Myeloma, NDMM, phase 3 study, progression-free survival, Sanofi, Sarclisa, transplant-eligible, VRd
(IN BRIEF) Sarclisa (isatuximab) has been approved in China for use in combination with the VRd regimen to treat newly diagnosed multiple myeloma patients who are ineligible for autologous stem cell transplant. The approval is based on positive results from … Read the full press release
Posted in Business, Financial, France, Government, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Security & Safety, Technology
Tagged Approval, cancer treatment, CHINA, clinical trials, EU, FDA, global health, IMROZ study, isatuximab, Japan, Multiple Myeloma, Multiple Myeloma Treatment, new approvals, NMPA, oncology, Sanofi, Sarclisa, transplant-ineligible, VRd
(IN BRIEF) Sanofi’s Sarclisa has been approved by the European Union as the first anti-CD38 therapy in combination with VRd to treat adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. This approval is … Read the full press release
Posted in Business, European Union, Financial, France, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Security & Safety, Technology
Tagged CD38 monoclonal antibody, clinical development, clinical trials, European Union approval, FDA approval, hematologic malignancies, immunoscience, isatuximab, Multiple Myeloma, NDMM, oncology, orphan drug exclusivity, Sanofi, Sarclisa, transplant-ineligible, treatment breakthrough, VRd
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