GLOFITAMAB-GXBM INJ,SOLN

Clinical Criteria Summary

⇄ This criteria document covers 9 drugs .

See all drugs in this document

Indication: Relapsed or Refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL)
Pre-medication: Dexamethasone 16 mg IV

Indication: Relapsed or Refractory Multiple Myeloma (BCMA target)
REMS Requirement: Required
Pre-medication: Dexamethasone 20mg PO/IV, Diphenhydramine 25mg PO, Acetaminophen 650mg PO
Additional Supportive Meds: PJP prophylaxis, Antiviral prophylaxis

Indication: Relapsed or Refractory large B-cell lymphoma (CD20 target)
Pre-medication: Dexamethasone 15mg PO/IV, Diphenhydramine 50mg PO/IV, Acetaminophen 650-1000mg PO
Additional Supportive Meds: PJP prophylaxis, Antiviral prophylaxis

Indication: Relapsed or Refractory large B-cell lymphoma (CD20 target)
Pre-medication: Dexamethasone 20mg IV, Diphenhydramine 50mg PO/IV, Acetaminophen 500-1000 mg PO
Additional Supportive Meds: Obinutuzumab day 1, Tumor lysis prophylaxis if at risk, Antiviral prophylaxis, PJP prophylaxis

Indication: Relapsed or Refractory follicular lymphoma (CD20 target)
Pre-medication: Dexamethasone 20mg IV, Diphenhydramine 50-100 mg PO/IV, Acetaminophen 500-1000 mg

Indication: Relapsed or Refractory multiple myeloma (GPRC5D target)
REMS Requirement: Required
Pre-medication: Dexamethasone 16mg PO/IV, Diphenhydramine 50mg PO, Acetaminophen 650-1000mg PO
Additional Supportive Meds: Antiviral prophylaxis
Keratotoxicity Management Criteria: Topical emollients for erythema/rash; saliva replacement therapy (VA National Formulary products include Artificial Saliva Oral Spray, Lozenge, Liquid and Gel) for oral toxicities

Indication: Relapsed or Refractory multiple myeloma (BCMA target)
REMS Requirement: Required
Pre-medication: Dexamethasone 16mg PO/IV, Diphenhydramine 50mg PO/IV, Acetaminophen 650-1000mg PO
Additional Supportive Meds: Antiviral prophylaxis

Facility is not equipped to monitor and manage Cytokine Release Syndrome (CRS), if necessary
Patient unable to be hospitalized for step-up dose on Cycle 1, Day 8 and/or Day 15 followed by 24 hours of monitoring, if any grade of CRS is experienced on either day
Absolute Neutrophil Count < 1500/µL, Platelet count < 75,000/µL (if no bone marrow involvement)
Total bilirubin > 1.5 times the upper limit of normal (unless Gilbert’s syndrome or liver involvement)
Alanine transaminase (ALT), aspartate transaminase (AST) and alkaline phosphatase > 3 times the upper limit of normal (unless liver involvement)
Creatinine clearance < 50 ml/min
Active or uncontrolled infection
Unmanageable drug-drug interaction
Pregnancy
Lactating

Relapsed or refractory, diffuse large B-cell lymphoma (DLBCL) or large B-cell lymphoma (LBCL) arising from follicular lymphoma (FL)
Previously treated with > 2 prior lines of therapy (including 1 line with anti-CD20 monoclonal antibody)
Care is provided by a VA/VA Community Care oncology or hematology provider
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Goals of care and role of Palliative Care consult have been discussed and documented

For patients who can become pregnant and patients with partners who can become pregnant: Counseling provided on potential risks vs benefits of treatment and the use of effective contraception during therapy and for 1 month after stopping treatment.

Relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or large B-cell lymphoma (LBCL) arising from follicular lymphoma (FL) after > 2 lines of therapy (LOT)
Heavily pretreated population with median prior LOT of 3; includes patients with primary refractory disease, prior CAR T-cell therapy, and prior autologous hematopoietic stem cell transplantation (HSCT)

Monitor for neurologic toxicity, including ICANS; hold or discontinue based on severity
Monitor signs and symptoms of serious infections; treat appropriately
Monitor patients at risk for tumor flare
Advise patients of embryo-fetal toxicity and potential fetal harm; require use of effective contraception
Hospitalization recommended 24 hours after step up dose #1 and step up dose #2, if CRS occurs in cycle 1
If CRS > Grade 2 occurs with infusion, hospitalize during and for 24 hours after completion of subsequent infusion

Recommended per VA Oncology Clinical Pathway for multiply relapsed DLBCL if ASCT and CAR T-cell therapies are not an option and disease progression occurs following rituximab-bendamustine-polatuzumab
Listed as a preferred regimen in NCCN guidelines for 3L and subsequent therapy for DLBCL