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 ...
And the agency expanded the approval of bimekizumab (Bimzelx) to include psoriatic arthritis, non-radiographic axial spondyloarthritis, and ankylosing spondylitis, UCB Announced.
This latest FDA decision marks the first approval for SNY's Sarclisa as a first-line treatment for multiple myeloma patients.
The FDA approved Sanofi's Sarclisa (isatuximab) in combination with VRd as a first-line treatment for newly diagnosed ...
The US Food and Drug Administration (FDA) has approved Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as a first line treatment option for adult patients ...
In addition to other MM indications, Isatuximab's anti-CD38 competitor on the US market, daratumumab (Darzalex — Johnson & Johnson), also carries a first-line indication for transplant-ineligible MM ...