Elranatamab
- Generic Name
- Elranatamab
- Brand Names
- Elrexfio
- Drug Type
- Biotech
- CAS Number
- 2408850-14-4
- Unique Ingredient Identifier
- L0HR9A577V
- Background
Elranatamab is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager. It is a humanized immunoglobulin 2-alanine kappa antibody derived from two monoclonal antibodies (mAbs), an anti-BCMA mAb and an anti-CD3 mAb, each of which contributes one heavy chain and one light chain to drug structure. The resulting 4-chain bispecific antibody is covalently linked via five inter-chain disulfide bonds. On August 14, 2023, the FDA granted accelerated approval to elranatamab for the treatment of multiple myeloma.
- Indication
Elranatamab 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. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s).
- Associated Conditions
- Refractory Multiple Myeloma, Relapsed Multiple Myeloma
Korean Post Marketing Surveillance for ELREXFIO (Elranatamab).
- First Posted Date
- 2024-09-03
- Last Posted Date
- 2025-05-20
- Lead Sponsor
- Pfizer
- Target Recruit Count
- 150
- Registration Number
- NCT06581848
- Locations
- 🇰🇷
Pfizer Korea, Seoul, Korea, Republic of
Elranatamab in Patients with Relapsed or Refractory AL Amyloidosis
- First Posted Date
- 2024-08-23
- Last Posted Date
- 2024-11-18
- Lead Sponsor
- Brigham and Women's Hospital
- Target Recruit Count
- 49
- Registration Number
- NCT06569147
- Locations
- 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
A Study to Compare the Effects of Elranatamab (PF 06863135) Versus Standard of Care (SOC) in Patients With Multiple Myeloma (MM) in Germany and US
- First Posted Date
- 2024-07-16
- Last Posted Date
- 2024-07-16
- Lead Sponsor
- Pfizer
- Target Recruit Count
- 2
- Registration Number
- NCT06504524
- Locations
- 🇩🇪
Pfizer, Berlin, Germany
Outpatient and Intermittent Dosing of Elranatamab in Relapsed/Refractory Multiple Myeloma
- First Posted Date
- 2024-05-20
- Last Posted Date
- 2025-05-09
- Lead Sponsor
- Ontario Clinical Oncology Group (OCOG)
- Target Recruit Count
- 40
- Registration Number
- NCT06421675
- Locations
- 🇨🇦
Arnie Charbonneau Cancer Institute, Calgary, Alberta, Canada
🇨🇦Cross Cancer Institute, Edmonton, Alberta, Canada
🇨🇦Vancouver Cancer Center, Vancouver, British Columbia, Canada
Study of Elranatamab for Relapsed or Refractory Myeloma in Patients Previously Exposed to Three-drug Classes
- First Posted Date
- 2024-02-28
- Last Posted Date
- 2024-03-06
- Lead Sponsor
- PETHEMA Foundation
- Target Recruit Count
- 50
- Registration Number
- NCT06282978
- Locations
- 🇪🇸
Hospital Son Llàtzer, Palma De Mallorca, Illes Balears, Spain
🇪🇸Hospital Clínico Universitario de Santiago ~ CHUS, Santiago De Compostela, A Coruña, Spain
🇪🇸Institut Catala d'Oncologia (ICO) Badalona - Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain
A Study to Learn About the Effects of the Combination of Elranatamab (PF-06863135) and Iberdomide in Patients With Relapsed or Refractory Multiple Myeloma (MagnetisMM-30)
- First Posted Date
- 2024-01-22
- Last Posted Date
- 2025-05-20
- Lead Sponsor
- Pfizer
- Target Recruit Count
- 87
- Registration Number
- NCT06215118
- Locations
- 🇦🇺
Calvary Mater Newcastle, Waratah, New South Wales, Australia
🇺🇸Emory University Hospital Midtown, Atlanta, Georgia, United States
🇺🇸Emory University Hospital, Atlanta, Georgia, United States
Pre-transplant Purging and Post-transplant MRD-guided Maintenance Therapy with Elranatamab in Patients with High-risk Multiple Myeloma
- Conditions
- Post-transplant MRD-guided Maintenance TherapyMultiple MyelomaPre-transplant Purging
- Interventions
- Procedure: Stem cell transplant
- First Posted Date
- 2024-01-17
- Last Posted Date
- 2025-02-13
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 40
- Registration Number
- NCT06207799
- Locations
- 🇺🇸
MD Anderson Cancer Center, Houston, Texas, United States
Use of Elranatamab in Patients With High-risk Smoldering Multiple Myeloma
- First Posted Date
- 2023-12-27
- Last Posted Date
- 2024-10-18
- Lead Sponsor
- Stichting European Myeloma Network
- Target Recruit Count
- 50
- Registration Number
- NCT06183489
- Locations
- 🇳🇱
Erasmus MC, Rotterdam, Netherlands
🇮🇹Ospedale Santo Spirito Ospedale -Azienda Sanitaria Locale Di Pescara, Roma, Italy
🇮🇹A.O.U. Policlinico S. Martino - Ematologia, Genova, Italy
MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide)
- Conditions
- Multiple Myeloma
- Interventions
- First Posted Date
- 2023-11-30
- Last Posted Date
- 2025-05-20
- Lead Sponsor
- Pfizer
- Target Recruit Count
- 492
- Registration Number
- NCT06152575
- Locations
- 🇫🇷
Hôpital NOVO, Pontoise, Val-d'oise, France
🇺🇸Infirmary Cancer Care, Mobile, Alabama, United States
🇺🇸Beverly Hills Cancer Center, Beverly Hills, California, United States
Elranatamab in R/R Multiple Myeloma
- Conditions
- Refractory Multiple MyelomaRelapse Multiple MyelomaMultiple Myeloma
- Interventions
- First Posted Date
- 2023-11-18
- Last Posted Date
- 2024-04-15
- Lead Sponsor
- Massachusetts General Hospital
- Target Recruit Count
- 32
- Registration Number
- NCT06138275
- Locations
- 🇺🇸
Beth-Israel Deaconess Medical Center, Boston, Massachusetts, United States
🇺🇸Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸Massachusetts General Hospital, Boston, Massachusetts, United States
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.