Isatuximab Plus VRd Approved by FDA for Newly Diagnosed, …
WEB18 hours ago · An improvement in progression-free survival was reported with isatuximab plus VRd, with a 40% reduction in the risk of disease progression or death (hazard ratio = 0.60 [95% confidence interval (CI) = 0.44–0.81]; P = .0009); the median progression-free survival was not reached (NR; 95% CI = not reached to …
Isatuximab Approved First-Line for Transplant-Ineligible MM
WEB11 hours ago · Isatuximab's new approval is based on the open-label IMROZ trial in 446 patients randomized 3 ... He is an award-winning medical journalist who worked for several major news outlets before joining ...
FDA Approves Isatuximab/VRd in Newly Diagnosed Multiple …
WEB3 days ago · Transplant-ineligible patients 80 years or younger with NDMM in the prospective, open-label study across 102 sites and 21 countries were randomly assigned 3:2 to receive isa-VRd or VRd alone. Patients received 10 mg/kg of isatuximab intravenously once weekly for 5 weeks in the first 42-day cycle, followed by every other week up to cycle 4 ...
FDA Approves Isatuximab With VRd as First-Line Option for …
WEB2 days ago · At 60 months, PFS rates were 83.2% in the isatuximab-VRd arm and 45.2% in the VRd arm. 2 The median PFS was not reached in the isatuximab-VRd arm vs 54.3 months (95% CI, 45.2–not reached) in the ...
FDA approves isatuximab-irfc with bortezomib, lenalidomide, and ...
WEB3 days ago · On September 20, 2024, the Food and Drug Administration approved isatuximab-irfc (Sarclisa, Sanofi-Aventis U.S. LLC) with bortezomib, lenalidomide, and dexamethasone for adults with newly ...
Sanofi’s Sarclisa gains third FDA approval | Biotechnology | The ...
WEB9 hours ago · The US Food and Drug Administration (FDA) has approved Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as a first line treatment option for adult patients with newly diagnosed multiple myeloma (NDMM) who are not eligible for autologous stem cell transplant (ASCT).
FDA Approves Isatuximab Plus VRd for Newly Diagnosed, …
WEB2 days ago · Additional data showed the ORR was 91.3% in the isatuximab arm, which included a stringent CR (sCR) rate of 10.9%, a CR rate of 63.8%, a VGPR rate of 14.3%, and a PR rate of 2.3%.
FDA Approves Sarclisa with VRd | Int'l Myeloma Foundation
WEB3 days ago · According to a September 20, 2024, press release, the U.S. Food and Drug Administration (FDA) has "approved isatuximab-irfc (Sarclisa, Sanofi-Aventis U.S. LLC) with bortezomib, lenalidomide, and dexamethasone for adults with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT)." This approval was based on results of the phase III IMROZ clinical trial ...
Isatuximab, Bortezomib, Lenalidomide, and Dexamethasone for …
WEBJun 3, 2024 · Isatuximab-VRd was more effective than VRd as initial therapy in patients 18 to 80 years of age with newly diagnosed multiple myeloma who were ineligible to undergo transplantation.
Sarclisa® (isatuximab-irfc) Phase 3 trial met primary ... - Sanofi
WEBDec 7, 2023 · Sarclisa® (isatuximab-irfc) Phase 3 trial met primary endpoint of progression free survival in patients with newly diagnosed multiple myeloma not eligible for transplant. Sarclisa added to bortezomib, lenalidomide and dexamethasone (VRd) significantly reduced the risk of disease progression or death compared with VRd alone.
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