FDA approves isatuximab-irfc with bortezomib, lenalidomide, and ...
WEB1 day 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 ...
FDA Approves Isatuximab With VRd as First-Line Option for …
WEB15 hours 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/VRd in Newly Diagnosed Multiple …
WEB1 day ago · 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 during induction therapy. ... lenalidomide, and dexamethasone for newly diagnosed multiple myeloma. FDA. News release. September 20, 2024. Accessed September 20, 2024. https://shorturl.at/B8d3c;
Press Release: Sarclisa approved in the US as the first anti-CD38 ...
WEB14 hours ago · Premium News. Economics. Housing. Earnings. Tech. Crypto. Biden Economy. The Morning Brief. Markets. ... (FDA) has approved Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and ...
FDA Approves Sarclisa with VRd | Int'l Myeloma Foundation
WEB1 day 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 ...
FDA Approves Sarclisa In Newly Diagnosed Transplant-Ineligible …
WEB16 hours ago · The Food and Drug Administration (FDA) has approved Sarclisa (isatuximab-irfc) with Velcade (bortezomib), Revlimid (lenalidomide) and dexamethasone, a combination known as Isa-VRd, for the treatment of adults with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT, when a patient’s own stem cells are collected, stored and infused back into them ...
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, 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 New Therapy for Patients with Previously Treated …
WEBToday, the U.S. Food and Drug Administration approved Sarclisa (isatuximab-irfc), in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple...
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.