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Unmet Need in Multiple MyelomaMode of ActionAboutReimbursementStudy OverviewStudy Design and Baseline DemographicsEfficacy OutcomesFollow-up Analyses OutcomesClinical StudySafetyDosingMaterialsVideosEventsService SupportContact UsSupport & Resources

The content of this website has been produced in line with the ELREXFIO®▼ (elranatamab) Summary of Product Characteristics. For Elrexfio® (elranatamab) Prescribing Information for United Kingdom click here.​ ELREXFIO® (elranatamab) has a conditional marketing authorisation. A conditional marketing authorisation means that further evidence of efficacy and safety data are being collected. New information on this medicinal product will be reviewed when any relevant information of significance becomes available and at least every year. The licensing authority will review new information on this medicine at least every year and update the Summary of Product Characteristics as necessary.

ELREXFIO®▼ has demonstrated a generally manageable safety profile in multiple myeloma patients regardless of previous exposure to BCMA-directed therapy1​​​​​​

The safety database of ELREXFIO® includes 183 adult patients from the MagnetisMM-3 study, who received the recommended ELREXFIO® dosing regimen as monotherapy for multiple myeloma.1 

The MagnetisMM-3 study included patients who were refractory to at least one proteasome inhibitor, one immunomodulatory again and one anti-CD38 monoclonal antibody. These patients were either naive to prior BCMA-directed therapy (cohort A) OR had received prior BCMA-directed therapy or chimeric antigen receptor (CAR) T-cell therapy (cohort B). The median duration of treatment was 4.1 months (range: 0.03 to 20.3 months).1 ​​​​​​

Adverse event reactions in patients receiving ELREXFIO® at the recommended dose*1-4​​​​​​
System organ classAdverse reaction Frequency* 
(All grades)		n=183
Any grade, n (%)Grade 3 or 4, n (%)
Infections and infestationsPneumoniaaVery common70 (38.3)47 (25.7)
SepsisbVery common34 (18.6)24
(13.1)
Upper respiratory tract infectionVery common78
(42.6)		11
(6.0)
Urinary tract infectionVery common25
(13.7)		11
(6.0)
Cytomegalovirus infection (CMV)cCommon17
(9.3)		4
(2.2)
Blood and lymphatic system disordersNeutropeniaVery common84
(45.9)		81
(44.3)
AnaemiaVery common99
(54.1)		78
(42.6)
ThrombocytopeniaVery common66
(36.1)		48
(26.2)
LymphopeniaVery common55
(30.1)		51
(27.9)
LeukopeniaVery common34
(18.6)		24
(13.1)
Febrile neutropenia Common5
(2.7)		5
(2.7)
Immune system disordersCytokine release syndrome Very common106
(57.9)		1
(0.5)
HypogammaglobulinaemiaVery common30
(16.4)		5
(2.7)
Metabolism and nutrition disordersDecreased appetiteVery common50
(27.3)		2
(1.1)
Hypokalaemia Very common43
(23.5)		17
(9.3)
HypophosphataemiaCommon12
(6.6)		1
(0.5)
Nervous system disordersPeripheral neuropathydVery common31
(16.9)		2
(1.1)
HeadacheVery common36
(19.7)		0
(0)
Immune effector cell-associated neurotoxicity syndromeCommon6
(3.3)		2
(1.1)
Respiratory, thoracic and mediastinal disordersDyspnoeaVery common38
(20.8)		9
(4.9)
Gastrointestinal disordersDiarrhoeaVery common76
(41.5)		5
(2.7)
Nausea Very common40
(21.9)		0
(0)
Skin and subcutaneous tissue disordersRasheVery common51
(27.9)		0
(0)
Dry skinVery common40
(21.9)		0
(0)
Musculoskeletal and connective tissue disordersArthralgiaVery common47
(25.7)		3
(1.6)
General disorders and administration site conditionsInjection site reactionVery common70
(38.3)		0
(0)
PyrexiaVery common52
(28.4)		6
(3.3)
Fatigue Very common82
(44.8)		11
(6.0)
InvestigationsTransaminases increasedVery common31
(16.9)		10
(5.5)

Adapted from ELREXFIO® SmPC; Pfizer Ltd. Data on File. REF-L1A2109; Pfizer Ltd. Data on File. REF-L1A1045; Pfizer Ltd. Data on File. REF-L1A2107.1-4
Data cut off: 26 March 2024.

*Adverse reactions are listed according to the MedDRA system organ classification and by frequency. Frequency categories are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), very rare (< 1/10 000) and not known (frequency cannot be estimated from the available data).1

a. Pneumonia includes pneumonia, COVID-19 pneumonia, bronchopulmonary aspergillosis, lower respiratory tract infection bacterial, lower respiratory tract infection viral, pneumocystis jirovecii pneumonia, pneumonia adenoviral, pneumonia bacterial, pneumonia. cytomegaloviral, pneumonia fungal, pneumonia influenzal, pneumonia pseudomonal, pneumonia viral, atypical pneumonia, coronavirus pneumonia, pneumonia haemophilus, pneumonia pneumococcal, pneumonia respiratory syncytial viral.
b. Sepsis includes sepsis, bacteraemia, device related bacteraemia, device related sepsis, escherichia bacteraemia, escherichia sepsis, klebsiella sepsis, pseudomonal sepsis, septic shock, staphylococcal bacteraemia, staphylococcal sepsis, streptococcal sepsis, urosepsis, campylobacter bacteraemia.
c. CMV includes cytomegalovirus infection reactivation, cytomegalovirus infection, cytomegalovirus chorioretinitis, cytomegalovirus gastroenteritis, cytomegalovirus viraemia.
d. Peripheral neuropathy includes peripheral sensory neuropathy, paraesthesia, peripheral sensorimotor neuropathy, dysaesthesia, neuropathy peripheral, peripheral motor neuropathy, Guillain-Barre syndrome, hypoaesthesia, neuralgia, polyneuropathy.
e. Rash incudes dermatitis exfoliative, dermatitis exfoliative generalised, erythema, palmar-plantar erythrodysaesthesia syndrome, rash, rash erythematous, rash macular, rash maculo-papular, rash pustular, symmetrical drug-related intertriginous and flexural exanthema, epidermolysis.

Of the patients experiencing cytokine release syndrome (CRS) in the MagnetisMM-3 study, CRS events were manageable, with early onset and short duration1

57.9% of patients (n=106) receiving ELREXFIO® at the recommended dose in the MagnetisMM-3 trial (n=183) experienced CRS of any grade.1,5​​​​​

CRS events were manageable and resolved with appropriate interventions. Among patients who experienced CRS (n=106):1,5

  • Associated symptoms included: fever, hypoxia and hypotension
  • 34% (n=35) of patients received tocilizumab (or siltuximab) 
  • 15.1% (n=16) of patients received corticosteroids
The majority of CRS events occurred after the first step-up dose of ELREXFIO® (n=183)1
  • Recurrent CRS occurred in 13.1% (n=24) of patients1,5

Adapted from ELREXFIO® SmPC.1

Please refer to the ELREXFIO® SmPC for full symptom monitoring and early intervention information for CRS.

A minority of patients experienced ICANS events; most events were Grade 1 or 2, with early onset and short duration1​​​​​​

In patients receiving ELREXFIO® at the recommended dose in the MagnetisMM-3 trial (n=183):1,6

  • 3.3% (n=6) of patients experienced ICANS events, with 2.7% (n=5) being after the first step-up dose  
  • Among patients who developed ICANS (n=6):1
  • 66.7% (n=4) received corticosteroids 
  • 33.3% (n=2) received tocilizumab (or siltuximab) 
  • 33.3% (n=2)received levetiracetam  
  • 16.7% (n=1) received anakinra 
  • The most frequent symptoms of ICANS included a depressed level of consciousness and Grade 1 or Grade 2 Immune Effector Cell-Associated Encephalopathy (ICE) scores1
  • The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS1

Please refer to the ELREXFIO® SmPC for full symptom monitoring and early intervention information for ICANS. 

BCMA: B-cell maturation antigen; CAR: chimeric antigen receptor; CD38: cluster of differentiation 38; CRS: cytokine release syndrome; ICANS: immune effector cell-associated neurotoxicity syndrome; SmPC: Summary of Product Characteristics

References:

References:ELREXFIO® Summary of Product Characteristics.Pfizer Ltd. Data on File. REF-L1A2109.Pfizer Ltd. Data on File. REF-L1A1045.Pfizer Ltd. Data on File. REF-L1A2107.Pfizer Ltd. Data on File. REF-E1A2142. Pfizer Ltd. Data on FIle. REF-E1A2143.

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Unmet Need in Multiple MyelomaMode of ActionAboutMagentisMM-3 Study OverviewMagnetisMM-3 Study Design and Efficacy OutcomesMagnetisMM-3 Study Safety ProfileMagnetisMM-3 StudySafetyDosingMaterialsVideosSupport & Resources
DosingELREXFIO® step-up dosing schedule recommended to reduce the incidence and severity of CRS and ICANS Read moreLoadingMagnetisMM-3 overviewEfficacy and safety reported from the BCMA-directed therapy-naïve cohort of the Phase 2 MagnetisMM-3 study (n=123) Read moreLoading
PP-L1A-GBR-0879. August 2025

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Adverse events should also be reported to Pfizer Medical Information on 01304 616161

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