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What Is Elrexfio?  

ELREXFIO™ (also known as elranatamab-bcmm, the generic drug name) is a B-cell maturation antigen (BCMA)-CD3-directed bispecific antibody immunotherapy. In August 2023, the U.S. FDA granted accelerated approval of Elrexfio for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. 

How Does Elrexfio Work?  

Elrexfio binds to a B-cell maturation antigen (BCMA) on myeloma cells and CD3 on T-cells. By doing so, it brings these cells together and stimulates the T-cells to eliminate the myeloma cells effectively. 

How Does Elrexfio Differ from CAR T-cell Therapy?  

Elrexfio differs from CAR T-cell therapy in that there is no need to collect the patient’s T cells. Instead, Elrexfio engages the patient’s T cells directly after injection. Not having to collect, engineer, and manufacture T cells over several weeks shortens the time-to-treatment for the myeloma patient.  

When Should Elrexfio Be Used as a Treatment?  

Elrexfio is FDA-approved for patients with relapsed or refractory myeloma who have received at least 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.  

How Has Elrexfio Been Used in Clinical Trials?  

MagnetisMM-3 Trial  

The approval of Elrexfio is supported by data on response rates and duration of response. In the phase II MagnetisMM-3 study (NCT04649359), meaningful responses were observed in heavily pretreated patients with relapsed/refractory multiple myeloma who were treated with Elrexfio as their first therapy targeting B-cell maturation antigen (BCMA).  

  • Specifically, among the patients who had received four or more prior lines of therapy before Elrexfio, the overall response rate was 58%, with 82% of patients maintaining their response for at least nine months.  
    • The median time to first response was 1.2 months. 
    • This study also established Elrexfio as the first BCMA-targeted therapy in the U.S. to use once-every-other-week dosing for patients who respond to the therapy after 24 weeks of receiving it weekly, which may reduce time spent at the clinic and potentially improve long-term treatment tolerability. 
  • The label also includes data from cohort B of the MagnetisMM-3 study, where 33% of patients who had received at least four prior lines of therapy including a BCMA-targeted therapy achieved an overall response after a median follow-up of 10.2 months, with 84% of these patients maintaining their response for at least nine months.  
  • Notably, longer-term efficacy data from cohort A presented at the 2023 European Hematology Association meeting showed an objective response rate of 61%, and median duration of response, overall survival, and progression-free survival had not yet been reached at a median follow-up of 14.7 months.  
    • Among responding patients, there was a 72% probability of maintaining a response at 15 months.  
    • Among responders who switched to every-other-week dosing at least six months before the data cut-off date, 80% maintained or improved their response, with 38% achieving a complete response or better. 

How Will Elrexfio Be Made Available to Patients? 

Because of its unique toxicities, Elrexfio will be made available to patients through a special REMS program. A REMS program is a Risk Evaluation and Mitigation Strategy (REMS). It is “a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.” 

How Should Elrexfio Be Administered, Dosed, and Scheduled? 

The International Myeloma Foundation (IMF) will soon be releasing a full booklet on Elrexfio. Until it becomes available, the IMF encourages patients to follow the dosing information on the manufacturer’s website here.  

Elrexfio Dosing Schedule

Dosing Schedule Day Elrexfio Dose Elrexfio Dose
Step-Up Dosing Schedule Day 1 Step-up dose 1 12 mg
Step-Up Dosing Schedule Day 4 Step-up dose 2 32 mg
Step-Up Dosing Schedule Day 8 First treatment dose 76 mg
Weekly Dosing Schedule One week after first treatment dose and weekly thereafter through week 24 Subsequent treatement dose 76 mg
Biweekly (Every 2 Weeks) Dosing Schedule* Week 25 and every 2 weeks thereafter Subsequent treatment dose 76 mg

*Responders only week 25 onward.

What Warnings and Precautions Should Patients Who Undergo Elrexfio Therapy Be Aware Of?  

The International Myeloma Foundation (IMF) will soon be releasing a full booklet on Elrexfio. Until it becomes available, the IMF encourages patients to learn about potential Elrexfio side effects and complications on the manufacturer’s website here.   

The medication label provides full details. 

 

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