Elrexfio

Multiple myeloma — relapsed or refractory, after at least four prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody

Step-up: Day 1: 12 mg SC, Day 4: 32 mg SC
Full dose: Day 8 and every week thereafter: 76 mg SC
After cycle 24 with best response ≥partial response: May switch to every 2 weeks
Pre-medication (1-3 hours before step-up and first full dose): Dexamethasone, acetaminophen, antihistamine
Hospitalize 48 hours after each step-up dose

Injection: 44 mg/1.1 mL and 76 mg/1.9 mL solution in single-dose vials

None listed.

• CRS: 58% (0.7% Grade ≥3). Primarily during step-up phase.
• Neurologic Toxicity: 30% (3% Grade ≥3).
• Infections: 69% (34% Grade ≥3). Including COVID-19, pneumonia, sepsis. Fatal infections reported.
• Cytopenias: Lymphopenia 83% (78% Grade 3-4), neutropenia 56% (49% Grade 3-4), anemia 49% (34% Grade 3-4).
• Hepatotoxicity: 11% Grade ≥3 transaminase elevations. Monitor LFTs.
• Hypogammaglobulinemia: 15%.

Infections (69%), CRS (58%), fatigue (37%), musculoskeletal pain (33%), diarrhea (29%), pneumonia (22%), nausea (20%), pyrexia (18%), injection site reactions (16%), neutropenia (56%), lymphopenia (83%), anemia (49%)

CRS in 58% (Grade 3 in 0.7%). ICANS in 3.4%. Hepatotoxicity: Grade 3+ AST/ALT in 4%. Grade 3+ infections in 19%.

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

CRS in 58% (Grade 3 in 0.7%). ICANS in 3.4%. Hepatotoxicity: Grade 3+ AST/ALT in 4%. Grade 3+ infections in 19%.

Consult the complete prescribing information for drug interactions, including effects on CYP enzymes, transporters, and concomitant medications that may require dose adjustments or monitoring.

Consult the full prescribing information for pregnancy-related considerations.

Refer to prescribing information for lactation guidance.

Pediatric safety and efficacy information is detailed in the full label.

Dose modifications for organ impairment are specified in the complete prescribing information.

Elranatamab is a humanized bispecific IgG2 monoclonal antibody targeting BCMA on myeloma cells and CD3 on T cells. Similar to teclistamab, it redirects T cells to BCMA-expressing tumor cells, but uses a different IgG subclass and binding configuration.

Half-life: approximately 13 days at target dose. Step-up dosing reduces CRS risk. Steady-state by Cycle 4 with q2w maintenance. Non-linear PK due to target-mediated drug disposition.

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

• MagnetisMM-3 — Elranatamab in relapsed/refractory MM after ≥3 prior lines. Phase II.
  🔬 NCT04649359 ↗ 📄 Primary Publication ↗

Elrexfio has FDA-approved indications across the following cancer types covered on PipelineEvidence: