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 ...
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 ...
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/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 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%.
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 …
FDA Approves Isatuximab Plus VRd in Transplant-Ineligible …
WEB2 days ago · Isatuximab plus VRd (isa-VRd) is now an FDA-approved combination for the treatment of patients with transplant-ineligible, newly diagnosed multiple myeloma, making it the first anti-CD38 therapy available in this patient population plus VRd. 1. In May 2024, the supplemental biologics license application of isatuximab for this indication was ...
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 ...
FDA Approves Isatuximab-Irfc With Bortezomib, Lenalidomide, …
WEBThe recommended isatuximab-irfc dose is 10 mg/kg per actual body weight, administered as an IV infusion. See the full prescribing information on Drugs@FDA for the dosage recommendations for the other drugs. The applicant used the Assessment Aid to facilitate the FDA’s review. The FDA granted the application priority review and orphan drug ...
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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