FDA Approves Elrexfio for Multiple Myeloma on August 14, 2023

Jul 22, 2024

What is Elrexfio prescribed for?  

Elrexfio is prescribed to treat adults with relapsed or refractory multiple myeloma who have received at least four prior therapies.

What is the name of the drug and what does it do?

The name of the drug is Elrexfio, pronounced el-reks-fe-o, (generic name: elranatamab-bcmm). It is a prescription medication approved for treating adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy. 

Elrexfio helps to target and eliminate cancerous cells in the bone marrow.

How does it work?

Elrexfio is a type of cancer treatment specifically designed to target and destroy myeloma cells, which are a type of cancer cell found in bone marrow. 

It works like a double-ended hook: one end attaches to a marker called BCMA that’s found only on the surface of myeloma cells, and the other end attaches to a marker called CD3 on the surface of T-cells, which are important immune cells in our body.

By binding to both these markers, Elrexfio pulls the T-cells directly to the myeloma cells. This close proximity triggers the T-cells to activate and aggressively attack the myeloma cells, leading to their destruction. 

This process harnesses the body’s own immune system to fight the cancer, making it a targeted and effective approach to treatment.

What did the research discover?

Clinical trials evaluated the safety and effectiveness of Elrexfio in patients with relapsed or refractory multiple myeloma who had undergone at least four prior therapies. 

These therapies included a proteasome inhibitor (a type of drug that blocks the breakdown of proteins in cells), an immunomodulatory agent (a drug that modifies the immune response), and an anti-CD38 monoclonal antibody (a drug that targets a specific protein on cancer cells).

The trials showed that many patients experienced a significant reduction in tumor size or achieved complete remission, meaning their cancer became undetectable after treatment. 

The response to Elrexfio was durable, providing long-lasting relief from the disease.

What are some of the side effects?

The side effects listed are from the product manufacturer. As health scientists, we share this information to keep you informed without causing undue worry. Many side effects diminish over time, and not all patients experience them. If prescribed medication, take it as directed and consult your healthcare professional if you have any concerning side effects.

  • Cytokine release syndrome (CRS)(A severe immune reaction that can cause fever, low blood pressure, and difficulty breathing)
  • Neurologic toxicity(Confusion, difficulty speaking, or seizures)
  • Infections(Serious infections, including bacterial, viral, or fungal infections)
  • Cytopenias(Low levels of blood cells, such as neutrophils and platelets, which can increase the risk of infection and bleeding)
  • Skin toxicity(Reactions including rashes and other skin disorders)
  • Hepatotoxicity(Elevated liver enzymes indicating potential liver damage)

What are the dosage recommendations and how is it prescribed?

Elrexfio is given as a subcutaneous injection (an injection under the skin). The recommended dosing schedule includes step-up doses to reduce the risk of severe side effects like CRS:

  • Day 1: Step-up dose of 12 mg
  • Day 4: Step-up dose of 32 mg
  • Day 8: First treatment dose of 76 mg

After the initial step-up phase, Elrexfio can be given weekly (76 mg) for 24 weeks. 

If the patient shows a good response, the dosage can be shifted to every two weeks. 

Hospitalization for 48 hours is recommended after the first step-up dose and for 24 hours after the second step-up dose to monitor for severe reactions.

Source:

  1. Highlights of Prescribing Information for Elrexfio. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761345Orig1s000lbl.pdf. Accessed 16 July 2024.

2. Drug Trials Snapshots: ELREXFIO. FDA. Available from: https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-elrexfio. Accessed 16 July 2024.

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