SARCLISA


Associated tags: Dexamethasone, Patient, Multiple myeloma, Lenalidomide, Isatuximab, Safety, Bortezomib, Standard of care, Progression-free survival, Carfilzomib, Cell, AOU, NCAA University Division, ASH, University, ASCT, Odds ratio, University of Turin, Society, Young

Press Release: Sarclisa accepted for FDA priority review for the treatment of transplant-ineligible newly diagnosed multiple myeloma

Retrieved on: 
Monday, May 27, 2024
Lenalidomide, Patient, Progression-free survival, Bortezomib, Priority, Food, Diagnosis, FDA, PFS, Trial of the century, Disease, Safety, EHA, Multiple myeloma, Dexamethasone, ASCO, Society, Priority review, European, Annual general meeting, Pharmaceutical industry

The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for the investigational use of Sarclisa (isatuximab) in combination with bortezomib, lenalidomide and dexamethasone (VRd) for the treatment of patients with transplant-ineligible newly diagnosed multiple myeloma (NDMM).

Key Points: 
  • The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for the investigational use of Sarclisa (isatuximab) in combination with bortezomib, lenalidomide and dexamethasone (VRd) for the treatment of patients with transplant-ineligible newly diagnosed multiple myeloma (NDMM).
  • 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.
  • “Despite recent advancements in multiple myeloma treatment, there remains a significant unmet need for new frontline therapies, particularly for transplant-ineligible patients who can face poor outcomes from the disease.
  • The safety and tolerability of Sarclisa observed in this study was consistent with the established safety profile of Sarclisa and VRd.

Press Release: Sarclisa® (isatuximab) plus KRd significantly improved rate of minimal residual disease negativity in transplant-eligible patients with newly diagnosed multiple myeloma versus KRd alone

Retrieved on: 
Monday, December 11, 2023
Isatuximab, ASCT, ITT, Associate, Bone marrow, EMN, MRD, Young, Multiple myeloma, Society, University of Turin, Lenalidomide, Odds ratio, ASH, University, Dexamethasone, NCAA University Division, AOU, Cell, Patient, Carfilzomib

The Phase 3 trial investigating Sarclisa® (isatuximab) in combination with carfilzomib, lenalidomide and dexamethasone (KRd) showed a statistically significant improvement in the rate of minimal residual disease (MRD) negativity, compared with KRd alone, after autologous stem cell transplant (ASCT) consolidation in transplant-eligible patients with newly diagnosed multiple myeloma (MM).

Key Points: 
  • The Phase 3 trial investigating Sarclisa® (isatuximab) in combination with carfilzomib, lenalidomide and dexamethasone (KRd) showed a statistically significant improvement in the rate of minimal residual disease (MRD) negativity, compared with KRd alone, after autologous stem cell transplant (ASCT) consolidation in transplant-eligible patients with newly diagnosed multiple myeloma (MM).
  • The respective rates of MRD negativity at sensitivity of 10-6 were 67% versus 48% (OR 1.93; p=0.006).
  • There was a statistically significant difference in MRD negativity rates after induction with Sarclisa in combination with KRd versus KRd (10-5: 45% versus 26%, p
  • Effective front-line treatment is critical for newly diagnosed patients, because achieving undetectable levels of disease early in the treatment journey may lead to better long-term outcomes.

Press Release: Sarclisa® (isatuximab) Phase 3 trial met primary endpoint of progression free survival in patients with newly diagnosed multiple myeloma not eligible for transplant

Retrieved on: 
Thursday, December 7, 2023
Progression-free survival, Multiple myeloma, Lenalidomide, Standard of care, Dexamethasone, Bortezomib, Patient, Safety, PFS

First global Phase 3 study to report positive results with an anti-CD38 therapy in combination with VRd in transplant-ineligible patients, reinforcing the potential for Sarclisa as a best-in-class medicine

Key Points: 
  • First global Phase 3 study to report positive results with an anti-CD38 therapy in combination with VRd in transplant-ineligible patients, reinforcing the potential for Sarclisa as a best-in-class medicine
    PARIS, December 7, 2023.
  • The Phase 3 IMROZ trial evaluating the investigational use of Sarclisa® (isatuximab) in combination with standard-of-care bortezomib, lenalidomide and dexamethasone (VRd) met its primary endpoint at a planned interim analysis for efficacy, demonstrating statistically significant improvement in progression-free survival (PFS) compared with VRd alone in transplant-ineligible patients with newly diagnosed multiple myeloma (MM).
  • This is also the second Phase 3 trial investigating Sarclisa in newly diagnosed patients to show superiority versus standard of care.
  • "This is the second Phase 3 trial investigating Sarclisa in newly diagnosed patients to show superiority versus standard of care, reinforcing our belief in Sarclisa as a best-in-class medicine.