elranatamab
elranatamab: developed by 1 company · 16 clinical trials tracked · 1 FDA decision.
elranatamab evidence translation
What we can confirm
1 FDA record · 16 tracked trials
What it means
What to watch
Prepared research question
How could elranatamab → PFE affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence1 indications · 5 study sponsors
Development Pipeline (1)
| Company | Phase |
|---|---|
| PFIZER INC (PFE) | Phase 4 |
Clinical Trials (16)showing 10 most recent
HEME-25: Open-Label Feasibility Study of Elranatamab Utilized in Newly Diagnosed Plasmablastic Lymphoma With or Without HIV in Consolidation After Definitive Therapy
Primary endpoint: Evaluation of Elra consolidation therapy
ELDORADO: a Randomized Phase II Trial of Elranatamab or Daratumumab in Combination With Lenalidomide, Bortezomib, and Dexamethasone (RVd Lite) in Newly Diagnosed, Transplant Ineligible/Deferred Multiple Myeloma
Primary endpoint: Proportion Patients who test Negative for Minimal Residual Disease (MRD) at 10^-5 after 4 Treatment Cycles
A Phase II, Nonrandomized, Single-Arm Study of Elranatamab Outpatient Administration in Patients With Relapsed/Refractory Multiple Myeloma (CORE-MM)
Primary endpoint: Incidence of Cytokine Release Syndrome (CRS) in Cycle 1
Phase 2 Trial of Elranatamab With Cyclophosphamide in Relapsed/Refractory Multiple Myeloma
Primary endpoint: Complete response rate
A Phase 1B, Open-label, Multicenter Study to Evaluate the Safety and Preliminary Efficacy of Cemsidomide in Combination With Elranatamab in Relapsed/Refractory Multiple Myeloma Subjects
Primary endpoint: Safety and tolerability of cemsidomide in combination with elranatamab
A Phase 2 Study of Elranatamab in Combination With Isatuximab (ELISA) in Relapsed and Refractory Multiple Myeloma
Primary endpoint: Objective response rate (ORR)
Frontline T-cell Engager vs Autologous Stem Cell Transplant and Measurable Residual Disease (MRD)-Guided Sequential Intensification thERapy in Multiple Myeloma (FASTER)
Primary endpoint: Rate of MRD negativity after completion of Maintenance 1
A Study of Elranatamab Management With Outpatient and Intermittent Dosing in Relapsed/Refractory Multiple Myeloma
Primary endpoint: Hospitalization rate
Self-administration of Subcutaneous Elranatamab in the Patients' Homes. An Open Label, Phase Two, Prospective, Multi-center, Non-randomized, Sponsor-initiated Explorative Trial
Primary endpoint: Evaluate the safety of self-administration of Elranatamab in the patients' own homes assessed by checklist
Pre-transplant Purging and Post-transplant MRD-guided Maintenance Therapy With Elranatamab in Patients With High-risk Multiple Myeloma
Primary endpoint: Safety and adverse events (AEs)
FDA Decisions1 records
Frequently asked questions
Who is developing elranatamab?
elranatamab is being developed by PFIZER INC.
How many clinical trials involve elranatamab?
BioSniper tracks 16 clinical trials involving elranatamab.
What is elranatamab's latest FDA decision?
The most recent tracked FDA decision for elranatamab is Approval for 1 INDICATIONS AND USAGE ELREXFIO is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification of clin, dated August 14, 2023.