$FDA Approves Elrexfio for Relapsed or Refractory Multiple Myeloma After Four Prior Lines of Therapy$

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Oncology FDA APPROVAL ● FDA Approval

FDA Approves Elrexfio for Relapsed or Refractory Multiple Myeloma After Four Prior Lines of Therapy

FDA Published March 31, 2026 DOI ↗

Key Takeaway

Consider for RRMM after 4+ prior lines including PI, IMiD, and anti-CD38 mAb; requires step-up dosing with hospitalization.

The FDA has granted accelerated approval to Elrexfio 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 approval provides a new subcutaneous bispecific T-cell engager option targeting BCMA for a heavily pre-treated population. The approval is based on response rate and durability of response, with continued approval contingent upon verification of clinical benefit in confirmatory trials. The dosing regimen requires a step-up schedule with initial hospitalization to mitigate cytokine release syndrome (CRS) risk.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Elrexfio is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T‑cell engager.

Indication & Patient Population

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 may be contingent upon verification of clinical benefit in confirmatory trial(s).

Dosing & Administration

For subcutaneous injection only. Recommended dosing schedule: Step-up dose 1 of 12 mg on Day 1, step-up dose 2 of 32 mg on Day 4, first treatment dose of 76 mg on Day 8, then 76 mg weekly through week 24. For responders (partial response or better maintained for at least 2 months) after at least 24 weeks, transition to 76 mg every 2 weeks through week 48. For patients who maintain response after 24 weeks of biweekly dosing, transition to 76 mg every 4 weeks. Continue until disease progression or unacceptable toxicity. Patients should be hospitalized for 48 hours after the first step-up dose and 24 hours after the second step-up dose. Administer pre-treatment medications (acetaminophen 650 mg, dexamethasone 20 mg, diphenhydramine 25 mg) approximately 1 hour before the first three doses (step-up dose 1, step-up dose 2, first treatment dose). ELREXFIO should only be administered by a qualified healthcare professional with appropriate medical support to manage severe reactions.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Not reported in label.

Place in Therapy

Indicated for adult patients with relapsed or refractory multiple myeloma after at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

View Original Abstract ↓

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 clinical benefit in a confirmatory trial(s). ELREXFIO is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T‑cell engager 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). ( 1 )