(IN BRIEF) Sanofi has received approval from Japan’s Ministry of Health, Labour and Welfare for the subcutaneous formulation of Sarclisa, or isatuximab, in combination with approved standard-of-care regimens for multiple myeloma. The approval covers use with pomalidomide and dexamethasone, or … Read the full press release
Posted in European Union, France, Government, Healthcare, Pharma & Biotech, Science, Security & Safety, Technology
Tagged anemia, anti-CD38 monoclonal antibody, anticancer treatment, bortezomib, cancer treatment, carfilzomib, CirCLIQ on-body injector, COVID-19, dexamethasone, Enable Injections, enFuse platform, European Union, hematologic malignancy, immunological therapies, infusion reactions, injection-site reactions, IRAKLIA phase 3 study, isatuximab, Japan, Japan Approval of Sarclisa Subcutaneous Builds on Phase 3 IRAKLIA Study Results, Japan Approves Sanofi’s Sarclisa Subcutaneous for Newly Diagnosed and Relapsed Multiple Myeloma, Japan Ministry of Health Labour and Welfare, Kd, lenalidomide, manual subcutaneous injection, Multiple Myeloma, NCT05405166, NDMM, neutropenia, newly diagnosed multiple myeloma, non-inferior efficacy, objective response rate, Olivier Nataf, on-body injector, oncology, ORR, Pd, pharmacokinetics, pneumonia, pomalidomide, R/R MM, relapsed or refractory multiple myeloma, Sanofi, Sanofi’s Sarclisa Subcutaneous Approval in Japan Expands Treatment Delivery Options for Multiple Myeloma Patients, Sarclisa, standard-of-care regimens, Subcutaneous formulation, targeted therapies, thrombocytopenia, United States, upper respiratory tract infection, VRd
(IN BRIEF) Sanofi has secured European Commission approval for Sarclisa® subcutaneous administration in combination with standard-of-care regimens for multiple myeloma, covering all indications already approved for the intravenous version of the therapy in the EU. The approval makes Sarclisa the … Read the full press release
Posted in Business, European Union, France, Healthcare, Marketing, Pharma & Biotech, Science, Technology
Tagged anti-CD38 monoclonal antibody, anticancer therapy, biologic therapies, bortezomib, cancer care, carfilzomib, CirCLIQ OBI, Committee for Medicinal Products for Human Use, dexamethasone, Enable Injections, enFuse platform, European Commission, European Commission Approves Sanofi’s Sarclisa Subcutaneous Across Existing EU Multiple Myeloma Indications, European Medicines Agency, European Union, Healthcare Innovation, home administration, IRAKLIA phase 3 study, isatuximab, IZALCO phase 2 study, lenalidomide, MM, Mohamad Mohty, Multiple Myeloma, NCT05405166, NCT05704049, newly diagnosed multiple myeloma, Olivier Nataf, on-body injector, oncology, outpatient treatment, patient-centered care, pomalidomide, relapsed and refractory multiple myeloma, Saint-Antoine Hospital, Sanofi, Sanofi Advances Multiple Myeloma Care in Europe with First Anticancer Therapy Administered via On-Body Injector, Sanofi Secures EU Approval for Sarclisa Subcutaneous as First Anticancer Therapy Delivered Through an On-Body Injector, Sarclisa, Sarclisa IV, Sarclisa subcutaneous, Sarclisa Subcutaneous Approved in the EU as Sanofi Expands Flexible Treatment Options for Multiple Myeloma Patients, Sorbonne University, subcutaneous administration
(IN BRIEF) Sanofi has secured European Commission approval for Sarclisa in combination with VRd as an induction treatment for newly diagnosed multiple myeloma patients eligible for autologous stem cell transplant. The decision was based on part one of the GMMG-HD7 … Read the full press release
Posted in France, Healthcare, Pharma & Biotech
Tagged autologous stem cell transplant, bortezomib, cancer treatment, clinical trials, dexamethasone, EU approval, front-line therapy, German-speaking Myeloma Multicenter Group, GMMG-HD7, hematologic malignancies, ICARIA-MM, IKEMA, IMROZ, isatuximab, lenalidomide, MRD negativity, Multiple Myeloma, Olivier Nataf, oncology, progression-free survival, Sanofi, Sarclisa, transplant-eligible, VRd
(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) GSK has received approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for Blenrep combinations to treat adults with relapsed or refractory multiple myeloma. The approval follows positive results from the DREAMM-7 and DREAMM-8 phase III trials, … Read the full press release
Posted in Business, Environment, Financial, Government, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged anti-BCMA, antibody-drug conjugate, Blenrep, bortezomib, chemotherapy, clinical efficacy, clinical trials, DREAMM-7, DREAMM-8, global markets, GSK, Japan approval, Multiple Myeloma, oncology, orphan drug designation, overall survival, partnership, PDUFA, pomalidomide, progression-free survival, regulatory approval, sustainability, treatment options
(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
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