isatuximab
isatuximab: sourced relationships with 1 company · 35 clinical trials tracked · 1 FDA decision.
isatuximab evidence translation
What we can confirm
1 FDA record · 35 tracked trials
What it means
What to watch
Prepared research question
How could isatuximab → SNY affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence8 indications · 2 study sponsors
Dated Pipeline Records (1)
| Company | Dated record stage |
|---|---|
| Sanofi (SNY) Reported 2020-03-02 · Current development: unknownSource | Approved |
Clinical Trial Registry Records (35)showing 10 most recent
A Clinical Phase I/II, Multicenter, Open-label, National Study Evaluating Quintuplet Treat-ment With ISaTuximab, Bortezomib, Lenalidomide and Dexamethasone Plus Etentamig (Etenta-Isa-VRd) in Primary DiagnOsed High-Risk Multiple Myeloma Patients
Primary endpoint: Safety and tolerability (Phase I)
Determination 2 - Isatuximab, Iberdomide, Bortezomib and Dexamethasone Induction, Followed by Risk- and Response-Adapted Consolidation and Maintenance Therapy, in Transplant-Eligible Patients With Newly Diagnosed Multiple Myeloma (NDMM)
Primary endpoint: 3-Year Sustained Minimal Residual Disease (sMRD)-negative Complete Response (CR) Rate [Cohort 1] (Step 2)
A Phase I/II Study on the Safety and Efficacy of CD38 Monoclonal Antibody in the Treatment of Refractory Severe Aplastic Anemia
Primary endpoint: Incidence of adverse events
Phase III Open-Label, Randomised Study of Consolidation With AZD0120 (Dual-Targeting BCMA/CD19 CAR-T) vs Continuous Standard Therapy in NDMM Patients Ineligible for ASCT as Initial Therapy (DURGA-5)
Primary endpoint: PFS in NDMM who are ineligible to receive ASCT is measured to demonstrate the superiority of IsaVRd or DRd induction followed by AZD0120 compared to IsaVRd or DRd induction followed by continuous DRd or IsaRd.
Phase Ib/II Study of Selinexor in Combination With Carfilzomib, Subcutaneous Isatuximab Administered Via Investigational Device and Dexamethasone (SCID) for Patients With Relapsed and/or Relapsed Refractory Multiple Myeloma
Primary endpoint: Adverse Events
Use of Isatuximab, Dexamethasone and Lenalidomide in a Go-Slow Fashion for Ultra-Frail Patients With Multiple Myeloma: A Phase 2 Multicenter Study
Primary endpoint: Completion rate of 9 cycles of treatment
Isatuximab and Iberdomide as Immunotherapy for High Risk in Smouldering Myeloma
Primary endpoint: Treatment deliverability, measured by treatment discontinuation before completion of 26 cycles
A Multicenter, Single-arm Phase II Study to Assess the Safety, Tolerability, and Efficacy of Isatuximab in Adult Patients With Cytologic or Molecular Relapsed/Refractory CD38 Positive T-cell Acute Lymphoblastic Leukemia (GMALL-Isatuximab)
Primary endpoint: Proportion of patients with complete hematologic response (ORR= CR and CRi)
A Phase II Study of ISABELA: Isatuximab, Belantamab Mafodotin, Pomalidomide, and Dexamethasone in Relapsed and Refractory Multiple Myeloma
Primary endpoint: Overall Response Rate (ORR)
A Randomized Phase III Trial Assessing Iberdomide Versus Iberdomide Plus Isatuximab Maintenance Therapy Post Autologous Hematopoietic Stem Cell Transplantation in Patients With Newly Diagnosed Multiple Myeloma
Primary endpoint: Demonstration of superiority of iberdomide plus isatuximab compared to iberdomide with respect to bone marrow minimal residual disease (MRD).
FDA Decisions1 records
Frequently asked questions
Which companies have sourced relationships with isatuximab?
isatuximab has dated SEC/FDA relationship records for Sanofi.
How many clinical trials involve isatuximab?
BioSniper tracks 35 clinical trials involving isatuximab.
What is isatuximab's latest FDA decision?
The most recent tracked FDA decision for isatuximab is Approval for 1 INDICATIONS AND USAGE SARCLISA is indicated: in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor. in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy. in combination with bortezomib, lenalidomide, and dexamethasone, f, dated March 2, 2020.