FDA, Sarclisa
Sanofi's Sarclisa Secures FDA Approval For First-Line Multiple Myeloma, Marking Its Third US Approval
The FDA approved Sanofi's Sarclisa (isatuximab) in combination with VRd as a first-line treatment for newly diagnosed multiple myeloma patients ineligible for stem cell transplants. Sarclisa is the first anti-CD38 therapy with VRd to significantly reduce disease progression or death by 40%.
Sanofi's Sarclisa Gets FDA Nod for Expanded Use in Multiple Myeloma
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 with Velcade (bortezomib),
Sarclisa Approved for Transplant-Ineligible Newly Diagnosed Multiple Myeloma
The Food and Drug Administration (FDA) has approved Sarclisa ® (isatuximab-irfc) in combination with bortezomib, lenalidomide and dexamethasone (VRd) for the treatment of patients with newly diagnosed multiple myeloma (NDMM) who are not eligible for autologous stem cell transplant.
Sanofi wins US approval for multiple myeloma drug in newly diagnosed patients
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 multiple myeloma patients.
Sanofi’s Multiple Sclerosis Drug Slows Disease’s Progression
Sanofi’s experimental drug for a form of multiple sclerosis delayed the progression of disability by nearly a third, providing hope for patients for whom there’s currently no treatment.
FiercePharma3h
After Sanofi's first-line myeloma nod, J&J strikes back with new tranche of Darzalex data
Following the FDA's green light for a combo regimen of Sanofi’s Sarclisa in patients with newly diagnosed multiple myeloma ...
pharmaphorum4d
Sanofi's Sarclisa gets one up on rival Darzalex in myeloma
The FDA has approved Sarclisa (isatuximab) as a first-line therapy for blood cancer multiple myeloma as a combination regimen ...
Pharmabiz3d
US FDA approves anti-CD38 therapy, Sarclisa in combo with standard-of-care treatment for adult patients with NDMM who are not eligible for transplant
US FDA approves anti-CD38 therapy, Sarclisa in combo with standard-of-care treatment for adult patients with NDMM who are not eligible for transplant: Paris Tuesday, September 24, ...
FiercePharma7d
Sanofi breaks into first-line multiple myeloma with FDA approval for Sarclisa
Since an initial FDA go-ahead in 2020, Sanofi’s Sarclisa has been specifically approved for patients with previously treated ...
PharmiWeb4d
Sarclisa approved in the US as the first anti-CD38…
Approval based on positive results from the IMROZ phase 3 study demonstrating Sarclisa in combination with bortezomib, lenalidomide, and dexamethasone (VRd) significantly improved progression-free ...
Sanofi Says FDA Approves Sarclisa for Treatment of Blood Cancer Patients
Sanofi said the Food and Drug Administration has approved Sarclisa as a first line combined treatment option for adult patients with newly diagnosed multiple myeloma who aren't eligible for autologous ...
Cure Today7d
FDA Approves Sarclisa In Newly Diagnosed Transplant-Ineligible Multiple Myeloma
The Food and Drug Administration has approved Sarclisa as a first-line treatment for patients with multiple myeloma who are ...