Isatuximab Plus VRd Approved by FDA for Newly Diagnosed, …
WEB2 days 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 …
FDA Approves Isatuximab/VRd in Transplant-Ineligible NDMM
WEB5 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-irfc with bortezomib, lenalidomide, and ...
WEB5 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...
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.
FDA Approves Isatuximab With VRd as First-Line Option for …
WEB4 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 ...
Press Release: Sarclisa approved in the US as the first anti-CD38 ...
WEB4 days ago · PARIS, September 21, 2024.The US Food and Drug Administration (FDA) has approved Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as a first line ...
Sanofi US News
WEBJun 3, 2024 · Data from the IMROZ phase 3 study demonstrated Sarclisa (isatuximab-irfc) in combination with standard-of-care bortezomib, lenalidomide and dexamethasone (VRd) followed by Sarclisa-Rd (the IMROZ regimen) significantly reduced the risk of disease progression or death by 40%, compared to VRd followed …
Isatuximab Approved First-Line for Transplant-Ineligible MM
WEB2 days 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 ...
Phase 3 study results of isatuximab, bortezomib, lenalidomide, …
WEBMay 29, 2024 · In the Phase 3 IMROZ study (NCT03319667), we investigate the efficacy and safety of Isa-VRd vs VRd in transplant-ineligible NDMM pts. Methods: IMROZ is a global, prospective, randomized, open-label study done at 102 study sites in 21 countries.
FDA Approves Isatuximab Plus VRd for Newly Diagnosed, …
WEB4 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%.