(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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