MOSUNETUZUMAB-AXGB 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

Relapsed or refractory follicular lymphoma (FL) after 2 or more lines of therapy (LOT)
Accelerated approval based on response rate; contingent upon verification and description in a confirmatory trial

Follicular lymphoma grade 1-3a
ECOG PS 0-1
s/p > 2 LOT (including anti-CD20 mab and alkylating agent)
Patients with unfavorable characteristics: relapse after antiCD20 antibody, cytotoxic chemotherapy and lenalidomide or progression < 24 months from all prior treatments
Not a candidate for cellular therapy

Boxed warning for CRS
Monitor for neurologic toxicity, infections, cytopenias, tumor flare, and embryo-fetal toxicity
CRS incidence: Gr 1-28%; Gr 2-15%; Gr 3-2%; Gr 4-0.5%; recurrent CRS 11%

NCCN guidelines FL v3.2024: 3L and subsequent therapy; preferred regimen includes BiTE (mosunetuzumab)
VA Oncology Clinical Pathway: Multiply relapsed FL in patients with unfavorable characteristics who are not candidates for cellular therapy

Facility is not equipped to monitor and manage Cytokine Release Syndrome (CRS)
Absolute Neutrophil Count < 1000/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 < 60 ml/min
Active or uncontrolled infection
Unmanageable drug-drug interaction
Pregnancy
Lactating

Relapsed or refractory, 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 3 months after stopping treatment.