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MOAMOAStructural DesignMechanism of ActionBCMA as a Target in MMEfficacyEfficacyStudy DesignStudy Results: BCMA–naïveStudy Results: BCMA–exposedPatient ProfilesSafetySafetyCRSNeurologic ToxicityInfectionsAdverse ReactionsSelect Laboratory AbnormalitiesDosingTherapy ManagementTherapy ManagementELREXFIO Treatment JourneySerious Adverse Reaction ManagementResources and SupportResources and SupportEventsMaterialsVideosAccess SupportTreatment Locator
Prescribing InformationMedication GuideIndication ELREXFIO REMS Patient Site
Do you see patients like these in your practice?
Do you see patients like this in your practice?

These patient profiles are hypothetical and represent the types of patients typically seen in clinical practice.

James

Janet

James
  • 70-year-old with no prior BCMA-directed therapy
  • Diagnosed with MM ~7 years ago
James
  • 70-year-old with no prior BCMA-directed therapy
  • Diagnosed with MM ~7 years ago

  • Progressive hip pain and fatigue
  • ECOG PS 1
  • PET scan showed multiple scattered osseous lesions suspicious for myeloma
  • M-protein 2.3 g/dL; anemia (Hb 6.9 g/dL); borderline renal impairment (CrCl 50 mL/min); hypercalcemia (total serum calcium 11.4 mg/dL); serum β2-microglobulin 5.3 mg/L
  • 70% monoclonal bone marrow plasma cells
  • FISH results showed t(14;16)
  • R-ISS stage II
Initial presentation
James has cytogenetic abnormalities, and his MM is uncontrolled with current regimen
Treatment historyTreatment-related adverse events
  • Myelosuppression (prolonged cytopenias) related to therapy, including the most recent treatment with selinexor-Vd
  • Cardiotoxicity with carfilzomib (resolved with cessation of therapy)
TitleJames is a fast progressor and has undergone 4 lines of therapyCurrent presentationCurrent considerations
  • On routine follow-up, patient presented with an increase in M-protein of 2.3 g/dL over 2 consecutive blood assessments and rapidly declining hemoglobin levels
  • No additional bone lesions identified on PET scan
Clinical factors
  • Rapidly progressing disease (TTNT/speed of progression: 2 mo); unable to wait for CAR T-cell production
  • Transplant eligible based on age and fitness
  • Triple-class exposed
  • BCMA-directed therapy–naïve
  • High-risk cytogenetic abnormalities detected on FISH
Patient preferencesPatient would prefer not to be away from home for prolonged periods of time
James has rapidly progressing disease, cannot wait for CAR-T, and prefers not to be away from home for long
ELREXFIO was studied in a range of BCMA-naïve patients with characteristics similar to James's1ASCT=autologous stem cell transplant; BCMA=B-cell maturation antigen; CAR=chimeric antigen receptor; CAR-T=chimeric antigen receptor T-cell; CR=complete response; CrCl=creatinine clearance; CRS=cytokine release syndrome; Dd=daratumumab and dexamethasone; DKd=daratumumab, carfilzomib, and dexamethasone; DoR=duration of response; ECOG=Eastern Cooperative Oncology Group; EPd=elotuzumab, pomalidomide, and dexamethasone; FISH=fluorescence in situ hybridization; Hb=hemoglobin; MM=multiple myeloma; M-protein=monoclonal protein; PET=positron emission tomography; PR=partial response; PS=performance status; R-ISS=Revised International Staging System; TTNT=time to next treatment; Vd=bortezomib and dexamethasone; VRd=bortezomib, lenalidomide, and dexamethasone.CRS

CRS in MagnetisMM-3

 Explore more LoadingReference:Data on file. Pfizer Inc., New York, NY.
Janet
  • 74-year-old with no prior BCMA-directed therapy
  • Diagnosed with MM ~8 years ago
Janet
  • 74-year-old with no prior BCMA-directed therapy
  • Diagnosed with MM ~8 years ago

  • Nonspecific symptoms of lethargy and bone pain
  • ECOG PS 2
  • Radiography showed vertebral compression fractures
  • M-protein 2.98 g/dL; anemia (Hb 7.1 g/dL); renal impairment (CrCl 45 mL/min); serum β2-microglobulin 5.1 mg/L
  • 65% monoclonal bone marrow plasma cells
  • FISH results showed no high-risk cytogenetic abnormalities
  • R-ISS II ​​​​​​​
Initial presentationTitleJanet is a slow progressor, with no high-risk abnormalitiesTreatment historyTreatment-related adverse events
  • Peripheral neuropathy (Grade 2) related to bortezomib that subsequently resolved
  • Myelosuppression (prolonged cytopenias) related to therapy, including the most recent treatment with ICd
TitleJanet has finished 4 lines of treatment, with DoR of over a yearCurrent considerations

Current presentation

  • Patient presented with back pain. Imaging revealed new lytic bone lesions, and laboratory investigation revealed increasing M-protein
  • No high-risk cytogenetic abnormalities detected on repeat FISH

Clinical factors

  • Slowly progressing disease (TTNT/speed of progression: 14 mo)
  • Transplant ineligible due to anginal pain (NYHA Class III)
  • Triple-class exposed
  • BCMA-directed therapy–naïve
  • Comorbidities: Renal dysfunction (CrCl 45 mL/min); history of hypertension and coronary artery disease with anginal pain (NYHA Class III)
  • No high-risk cytogenetic abnormalities or extramedullary disease
Patient preferencesPatient is requesting a treatment plan that allows her to stay close to homeTitleJanet is an older patient, with significant comorbidities, and her disease is slowly progressingELREXFIO was studied in a range of BCMA-naïve patients with characteristics similar to Janet's1ELREXFIO was studied in a range of BCMA-naïve patients with characteristics similar to Janet's1

BCMA=B-cell maturation antigen; CR=complete response; CrCl=creatinine clearance; CRS=cytokine release syndrome; DoR=duration of response; DVd=daratumumab, bortezomib, and dexamethasone; ECOG=Eastern Cooperative Oncology Group; EPd=elotuzumab, pomalidomide, and dexamethasone; FISH=fluorescence in situ hybridization; Hb=hemoglobin; ICd=ixazomib, cyclophosphamide, and dexamethasone; MM=multiple myeloma; M-protein=monoclonal protein; NYHA=New York Heart Association; PR=partial response; PS=performance status; Rd=lenalidomide and dexamethasone; R-ISS=Revised International Staging System; TTNT=time to next treatment; VGPR=very good partial response; VRd=bortezomib, lenalidomide, and dexamethasone.

CRSCRS in MagnetisMM-3 Explore more LoadingReference:Data on file. Pfizer Inc., New York, NY.
Efficacy The efficacy of ELREXFIO was evaluated in the single-arm, Phase 2 MagnetisMM-3 study Efficacy Explore the data Loading ELREXFIO is available 
off-the-shelf for subcutaneous administration Dosing See the dosing schedule Loading

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INDICATION AND USAGEELREXFIO™ (elranatamab-bcmm) 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).
Important Safety InformationWARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME

Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving ELREXFIO. Initiate treatment with ELREXFIO step-up dosing to reduce risk of CRS. Withhold ELREXFIO until CRS resolves or permanently discontinue based on severity.

Neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS) and serious and life-threatening reactions, can occur in patients receiving ELREXFIO. Monitor patients for signs and symptoms of neurologic toxicity, including ICANS, during treatment. Withhold ELREXFIO until the neurologic toxicity resolves or permanently discontinue based on severity.

Because of the risk of CRS and neurologic toxicity, including ICANS, ELREXFIO is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called ELREXFIO REMS.

Cytokine Release Syndrome (CRS): ELREXFIO can cause CRS, including life-threatening or fatal reactions. In the clinical trial, CRS occurred in 58% of patients who received ELREXFIO at the recommended dose, 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: 1-9) days after the most recent dose, with a median duration of 2 (range: 1-19) days.

Clinical signs and symptoms of CRS may include, but are not limited to, fever, hypoxia, chills, hypotension, tachycardia, headache, and elevated liver enzymes.

Initiate therapy according to the ELREXFIO step-up dosing schedule to reduce risk of CRS and monitor patients following administration of ELREXFIO accordingly. Administer pretreatment medications prior to each dose in the step-up dosing schedule to reduce risk of CRS.

Counsel patients to seek medical attention should signs or symptoms of CRS occur. At the first sign of CRS, evaluate patients immediately for hospitalization. Manage CRS according to the recommendations and consider further management per current practice guidelines. Withhold or permanently discontinue ELREXFIO based on severity.

Neurologic Toxicity Including ICANS: ELREXFIO can cause serious or life-threatening neurologic toxicity, including ICANS.

In the clinical trial, neurologic toxicity occurred in 59% of patients who received ELREXFIO at the recommended dose, with Grade 3 or 4 neurologic toxicity occurring in 7% of patients. Neurologic toxicities included headache (18%), encephalopathy (15%), motor dysfunction (13%), sensory neuropathy (13%), and Guillain-Barré Syndrome (0.5%).

In the clinical trial, ICANS occurred in 3.3% of patients who received ELREXFIO at the recommended dose. Most patients had ICANS after the first step-up dose (2.7%), 1 (0.5%) patient had ICANS after the second step-up dose, and 1 (0.5%) patient had ICANS after subsequent dose(s). Recurrent ICANS occurred in 1.1% of patients. The median time to onset was 3 (range: 1-4) days after the most recent dose, with a median duration of 2 (range: 1-18) days. The most frequent clinical manifestations of ICANS included a depressed level of consciousness and Grade 1 or Grade 2 immune effector cell-associated encephalopathy (ICE) scores. The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS.

Counsel patients to seek medical attention should signs or symptoms of neurologic toxicity occur. Monitor patients for signs and symptoms of neurologic toxicities during treatment with ELREXFIO. At the first sign of neurologic toxicity, including ICANS, evaluate and treat patients immediately based on severity. Withhold or permanently discontinue ELREXFIO based on severity per recommendations and consider further management per current practice guidelines.

Due to the potential for neurologic toxicity, including ICANS, patients receiving ELREXFIO are at risk of depressed level of consciousness. Advise patients not to drive or operate heavy or potentially dangerous machinery for 48 hours after completing each of the 2 step-up doses and the first treatment dose within the ELREXFIO step-up dosing schedule and in the event of new onset of any neurologic toxicity symptoms until symptoms resolve.

REMS: ELREXFIO is available only through a restricted program under a REMS called the ELREXFIO REMS because of the risks of CRS and neurologic toxicity, including ICANS.

Hepatotoxicity: ELREXFIO can cause hepatotoxicity. In the clinical trial, elevated ALT occurred in 36% of patients, with Grade 3 or 4 ALT elevation occurring in 3.8%; elevated AST occurred in 40% of patients, with Grade 3 or 4 AST elevation occurring in 6%. Grade 3 or 4 total bilirubin elevations occurred in 0.5% of patients. Liver enzyme elevation can occur with or without concurrent CRS.

Monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated. Withhold ELREXFIO or consider permanent discontinuation of ELREXFIO based on severity.

Infections: ELREXFIO can cause severe, life-threatening, or fatal infections. In the clinical trial, in patients who received ELREXFIO at the recommended dose, serious infections, including opportunistic infections, occurred in 42% of patients, with Grade 3 or 4 infections in 31% and fatal infections in 7%. The most common serious infections reported (≥5%) were pneumonia and sepsis.

Do not initiate treatment with ELREXFIO in patients with active infections. Monitor patients for signs and symptoms of infection prior to and during treatment with ELREXFIO and treat appropriately. Withhold or permanently discontinue ELREXFIO based on severity. Administer prophylactic antimicrobial and antiviral medications according to current practice guidelines. Consider treatment with subcutaneous or intravenous immunoglobulin (IVIG) as appropriate.

Neutropenia: ELREXFIO can cause neutropenia and febrile neutropenia. In patients who received ELREXFIO at the recommended dose in the clinical trial, decreased neutrophils occurred in 62% of patients, with Grade 3 or 4 decreased neutrophils in 51%. Febrile neutropenia occurred in 2.2% of patients.

Monitor complete blood cell counts at baseline and periodically during treatment. Provide supportive care according to current practice guidelines. Monitor patients with neutropenia for signs of infection. Withhold ELREXFIO based on severity.

Embryo-Fetal Toxicity: Based on its mechanism of action, ELREXFIO may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with ELREXFIO and for 4 months after the last dose.

Adverse Reactions: In patients who received ELREXFIO, the most common adverse reactions (incidence ≥20%) were 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 or 4 laboratory abnormalities (≥30%) were decreased lymphocytes, decreased neutrophils, decreased hemoglobin, decreased white blood cells, and decreased platelets.

Please see full Prescribing Information, including BOXED WARNING, and Medication Guide for ELREXFIO.ELREXFIO™ (elranatamab-bcmm) 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).Indication and Usage