(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, an anti-CD38 treatment developed by Sanofi, has been approved in China for treating adult patients with relapsed or refractory multiple myeloma (R/R MM) who have received at least one prior therapy. The approval is based on the … Read the full press release
Posted in Business, Financial, France, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Security & Safety, Technology
Tagged anti-CD38 antibody, autologous stem cell transplant, bortezomib, CACA, Category I Recommendation, Chinese Anti-Cancer Association, Chinese Society of Clinical Oncology, clinical data, CSCO, dexamethasone, Global Head of Oncology, ICARIA-MM phase 3 study, innovative regulatory pathways, innovative therapies, IsaFiRsT real-world study, Lecheng Pilot Program, lenalidomide, local authorities, medical community, National Medical Products Administration, newly diagnosed multiple myeloma, NMPA, Olivier Nataf, overall response rate, overall survival, Pd, pomalidomide, R/R MM, real-world evidence, regulatory submission, relapsed or refractory multiple myeloma, RWE, Sanofi, Sanofi in China, Sarclisa
(IN BRIEF) In the Phase 3 IsKia trial presented at the American Society of Hematology (ASH) Annual Meeting, Sarclisa® (isatuximab) combined with carfilzomib, lenalidomide, and dexamethasone (KRd) demonstrated a significant improvement in achieving minimal residual disease (MRD) negativity among newly … Read the full press release
Posted in Business, Education, Financial, France, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Technology
Tagged carfilzomib, Combination Therapy, dexamethasone, Francesca Gay, lenalidomide, Myeloma, Peter C. Adamson, Phase 3 Trial, Remission Rates, Sanofi, Sarclisa
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