Elranatamab

Elranatamab-bcmm is a bispecific B-cell maturation antigen (BCMA)-directed T-cell engaging antibody that binds BCMA on plasma cells, plasmablasts, and multiple myeloma cells and CD3 on T-cells leading to cytolysis of the BCMA-expressing cells. Elranatamab-bcmm activated T-cells, caused proinflammatory cytokine release, and resulted in multiple myeloma cell lysis.

• 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) ] .ICD-10: C90.00

• None. None.contraindicated

ELREXFIO Dosing Schedule ( 2.2 ) Dosing Schedule Day ELREXFIO Dose Step-up Dosing Schedule Day 1 Step-up dose 1 12 mg Day 4 Step-up dose 2 32 mg Day 8 First treatment dose 76 mg Weekly Dosing Schedule One week after first treatment dose and weekly thereafter through week 24 Subsequent treatment doses 76 mg Biweekly (Every 2 Week) Dosing Schedule Responders only week 25 onward. Week 25 and every 2 weeks thereafter through week 48 Subsequent treatment doses 76 mg Every 4 Week Dosing Schedule In patients who have maintained the response following 24 weeks of treatment at the biweekly dosing schedule. Week 49 and every 4 weeks thereafter Subsequent treatment doses 76 mg • Patients should be hospitalized for 48 hours after administration of the first step-up dose, and for 24 hours after administration of the second step-up dose. ( 2.1 ) • For subcutaneous injection only. ( 2.2 ) • Administer pre-treatment medications as recommended. ( 2.3 ) • See Full Prescribing Information for instructions on preparation and administration. ( 2.6 ) 2.1 Important Dosing Information Administer ELREXFIO subcutaneously according to the step-up dosing schedule to reduce the incidence and severity of cytokine release syndrome (CRS). Administer pre-treatment medications prior to each dose in the ELREXFIO step-up dosing schedule, which includes step-up dose 1, step-up dose 2, and the first treatment dose as recommended [see Dosage and Administration (2.2 , 2.3 )] .

• Infections : Can cause severe, life-threatening, or fatal infections. Monitor patients for signs and symptoms of infection and treat appropriately. Do not initiate treatment in patients with active infections. ( 5.4 ) • Neutropenia : Monitor complete blood cell counts at baseline and periodically during treatment. ( 5.5 ) • Hepatotoxicity : Can cause elevated ALT, AST, and bilirubin. Monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated. ( 5.6 ) • Embryo-Fetal Toxicity : May cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception. ( 5.7 , 8.1 . 8.3 ) 5.1 Cytokine Release Syndrome (CRS) ELREXFIO can cause CRS, including life-threatening or fatal reactions [see Adverse Reactions (6.1) ] . In the clinical trial, CRS occurred in 58% of patients who received ELREXFIO at the recommended dosing schedule [see Dosage and Administration (2.2) ] , with Grade 1 CRS in 44% of patients, Grade 2 CRS in 14% of patients, and Grade 3 CRS in 0.5% of patients. Recurrent CRS occurred in 13% of patients. Most patients experienced CRS after the first step-up dose (43%) or the second step-up dose (19%), with 7% of patients having CRS after the first treatment dose and 1.6% of patients after a subsequent dose. The median time to onset of CRS was 2 (range: 1 to 9) days after the most recent dose, with a median duration of 2 (range: 1 to 19) days.

The following adverse reactions are discussed elsewhere in labeling: • Cytokine Release Syndrome [see Warnings and Precautions (5.1) ] . • Neurologic Toxicity, Including ICANS [see Warnings and Precautions (5.2) ] . • Infections [see Warnings and Precautions (5.4) ] . • Neutropenia [see Warnings and Precautions (5.5) ] . • Hepatotoxicity [see Warnings and Precautions (5.6) ] . Most common adverse reactions (incidence ≥20%) are CRS, fatigue, injection site reaction, diarrhea, upper respiratory tract infection, musculoskeletal pain, pneumonia, decreased appetite, rash, cough, nausea, and pyrexia. The most common Grade 3 to 4 laboratory abnormalities (≥30%) are decreased lymphocytes, decreased neutrophils, decreased hemoglobin, decreased white blood cells, and decreased platelets. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Relapsed/Refractory Multiple Myeloma MagnetisMM-3 The safety of ELREXFIO was evaluated in MagnetisMM-3 [see Clinical Studies (14) ]. The safety population described (n = 183) includes patients who received the recommended dosage regimen of 12 mg subcutaneously on Day 1, 32 mg on Day 4, and 76 mg once weekly starting on Day 8.

Lactation : Advise not to breastfeed. ( 8.2 ) 8.1 Pregnancy Risk Summary Based on the mechanism of action, ELREXFIO may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data on the use of ELREXFIO in pregnant women to evaluate for a drug associated risk. No animal reproductive or developmental toxicity studies have been conducted with ELREXFIO. Elranatamab-bcmm causes T-cell activation and cytokine release; immune activation may compromise pregnancy maintenance. In addition, based on the finding of B-cell depletion in non-pregnant animals, elranatamab-bcmm can cause B-cell lymphocytopenia in infants exposed to elranatamab-bcmm in-utero. Human immunoglobulin (IgG) is known to cross the placenta after the first trimester of pregnancy; therefore, elranatamab-bcmm has the potential to be transmitted from the mother to the developing fetus. Advise women of the potential risk to the fetus. ELREXFIO is associated with hypogammaglobulinemia, therefore, assessment of immunoglobulin levels in newborns of mothers treated with ELREXFIO should be considered. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Metabolism

Pharmacokinetic parameters are presented as geometric mean (coefficient of variation [CV]%) and are based upon subcutaneously administered unless otherwise specified. Elranatamab-bcmm exhibits dose proportional pharmacokinetics over dose range from 6 to 76 mg (0.079 to 1 times the approved recommended dosage).

• Aug 14, 2023BLABLA761345Pfizer Inc

1. 1Cytokine Release Syndrome16218%
2. 2Death859.7%
3. 3Pyrexia657.4%
4. 4Malignant Neoplasm Progression576.5%
5. 5Immune Effector Cell-associated Neurotoxicity Syndrome475.3%
6. 6Fatigue445.0%
7. 7Off Label Use445.0%
8. 8Cytomegalovirus Infection Reactivation434.9%
9. 9Pneumonia424.8%
10. 10Infection364.1%
11. 11Diarrhoea323.6%
12. 12Plasma Cell Myeloma313.5%
13. 13Neoplasm Progression283.2%
14. 14Neutropenia283.2%
15. 15Rash273.1%

The 10 most recently updated of 56 ClinicalTrials.gov registrations naming Elranatamab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study of Elranatamab Outpatient Administration in Patients With Relapsed/Refractory Multiple Myeloma
  Not yet recruiting · Phase 2 · Interventional · 46 enrolled · SCRI Development Innovations, LLC
  NCT07637578updated 2026-06-11
• 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)
  Recruiting · Phase 1 · Interventional · 87 enrolled · Pfizer
  NCT06215118updated 2026-06-10
• A Study to Learn About the Effects of the Combination of Elranatamab, Daratumumab and Lenalidomide Compared With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Transplant
  Recruiting · Phase 3 · Interventional · 1,116 enrolled · Pfizer
  NCT05623020updated 2026-06-09
• Elranatamab Post Trial Access Study for Participants With Multiple Myeloma (MM)
  Recruiting · Phase 4 · Interventional · 80 enrolled · Pfizer
  NCT06057402updated 2026-06-05
• 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)
  Recruiting · Phase 3 · Interventional · 492 enrolled · Pfizer
  NCT06152575updated 2026-06-05
• Frontline T-cell Engager vs Autologous Stem Cell Transplant (ASCT) and Measurable Residual Disease (MRD)-Guided Sequential Intensification thERapy in Multiple Myeloma
  Recruiting · Phase 2 · Interventional · 100 enrolled · SCRI Development Innovations, LLC
  NCT06974786updated 2026-06-04
• Study of Elranatamab for Relapsed or Refractory Myeloma in Patients Previously Exposed to Three-drug Classes
  Active not recruiting · Phase 2 · Interventional · 50 enrolled · PETHEMA Foundation
  NCT06282978updated 2026-06-04
• A Study Evaluating the Safety, Pharmacokinetics, and Activity of the Combination of Cevostamab and Elranatamab in Participants With Relapsed or Refractory Multiple Myeloma (R/R MM)
  Recruiting · Phase 1 · Interventional · 120 enrolled · Genentech, Inc.
  NCT05927571updated 2026-06-03
• AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Multiple Myeloma
  Recruiting · Phase 1 · Phase 2 · Interventional · 226 enrolled · AstraZeneca
  NCT06106945updated 2026-06-02
• Elranatamab/Lenalidomide Consolidation and/or Elranatamab Maintenance Versus Standard of Care After D-VRd Induction in Transplant-eligible NDMM Patients
  Recruiting · Phase 3 · Interventional · 824 enrolled · Intergroupe Francophone du Myelome
  NCT06918002updated 2026-06-01

Frequently asked questions

How does Elranatamab work?

Elranatamab-bcmm is a bispecific B-cell maturation antigen (BCMA)-directed T-cell engaging antibody that binds BCMA on plasma cells, plasmablasts, and multiple myeloma cells and CD3 on T-cells leading to cytolysis of the BCMA-expressing cells. Elranatamab-bcmm activated T-cells, caused proinflammatory cytokine release, and resulted in multiple myeloma cell lysis.

What is Elranatamab used for?

According to FDA labeling, Elranatamab carries indications including: 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) ] .. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Elranatamab?

Elranatamab is classified as Other monoclonal antibodies and antibody drug conjugates, CD3-directed Antibody Interactions, Increased Cytokine Activity.

What are the brand names for Elranatamab?

Elranatamab is marketed under brand names including Elrexfio.

What are the contraindications for Elranatamab?

Elranatamab labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.