ASCO: Sarclisa is first anti-CD38 to significantly improve ... - Sanofi
Jun 3, 2024 · If approved, Sarclisa would be the first anti-CD38 therapy in combination with standard-of-care VRd in newly diagnosed patients not eligible for transplant, which would be the third indication for Sarclisa in multiple myeloma.
Press Room - Sanofi US News
Aug 8, 2024 · Sarclisa (isatuximab) is a monoclonal antibody that binds to a specific epitope on the CD38 receptor on MM cells, inducing distinct antitumor activity. It is designed to work through multiple mechanisms of action including programmed tumor cell death (apoptosis) and immunomodulatory activity.
Press Room - Sanofi US News
Sep 20, 2024 · SARCLISA is the first anti-CD38 therapy in combination with standard-of-care VRd to significantly reduce disease progression or death (by 40%) compared to VRd alone for patients with NDMM not eligible for transplant. Thomas Martin M.D.
EMA’s CHMP recommends Sanofi’s Sarclisa approval for multiple …
14 hours ago · In This Article: SNY. The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Sanofi’s Sarclisa combined with Velcade, plus ...
Sanofi's Sarclisa Recommended for EU Approval - Morningstar
1 day ago · Provided by Dow Jones Nov 14, 2024 9:20am. By Pierre Bertrand. Sanofi said that Sarclisa, its treatment for plasma cell cancer, was recommended for EU approval by the European Medicines Agency ...
Sanofi: positive CHMP opinion for Sarclisa in myeloma
1 day ago · November 14, 2024 at 12:08 pm EST. Sanofi announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion on its marketing authorization application for Sarclisa (isatuximab), in combination with bortezomib, lenalidomide and dexamethasone (VRd protocol), for the first ...
Sanofi wins US approval for multiple myeloma drug in newly …
Sep 20, 2024 · The U.S. Food and Drug Administration said on Friday it has approved the use of a drug combination along with Sanofi's Sarclisa infusion as a treatment for certain types of newly diagnosed...
Sanofi's Sarclisa Gets FDA Nod for Expanded Use in Multiple …
Sep 23, 2024 · Sanofi SNY announced that the FDA has approved the label expansion for the use of its multiple myeloma (MM) drug, Sarclisa (isatuximab). With this nod, Sarclisa is now approved in combination...
Press Release: Sarclisa recommended for EU approval by the
1 day ago · Sanofi continues to advance Sarclisa as part of a patient-centric clinical development program, which includes several phase 2 and phase 3 studies across the MM treatment continuum spanning six ...
FDA approves Sarclisa with bortezomib, lenalidomide, and …
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...
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