AXATILIMAB-CSFR INJ,SOLN
Clinical Criteria Summary
Document 831: MON Axatilimab NIKTIMVO Monograph March 2026
Indication & Disease State
- Treatment of chronic graft-versus-host disease (cGVHD)
- Refractory or recurrent cGVHD with active signs/symptoms per NIH consensus criteria
Patient Eligibility & Demographics
- Adults/pediatric patients weighing at least 40kg
- Karnofsky score > 60
- Adequate organ function
Prior Therapy Requirements
- Failure of at least 2 prior lines of therapy
- s/p > 2 lines of therapy (median 4 lines in trial population)
- Prior therapies may include ibrutinib, ruxolitinib, or belumosudil
Disease Severity & Grading Criteria
- Chronic Graft NIH Consensus Criteria for organ scoring (Score 0-3: least to most impactful versus Host Disease Grading classified by symptoms, affected organ systems and extent of disease involvement)
- Mild: < 2 affected organs; no clinically significant functional dysfunction
- Moderate: > 3 organs with no dysfunction or > 1 organ with dysfunction but no major disability
- Severe: Major disability
Dosing & Administration Parameters
- 0.3 mg/kg (max 35 mg) IV over 30 min every 3 weeks
- IV formulation required
Document 838: Axatilimab NIKTIMVO Criteria March 2026
Exclusion Criteria
- Weight less than 40 kg
- Known pregnancy
- Lactating
Inclusion Criteria
- Care provided by a VA or VA Community Care hematology provider
- Eastern Cooperative Oncology Group Performance Status 0 - 2
- Chronic graft-versus-host disease progression after at least 2 prior lines of systemic therapy [that included ibrutinib, ruxolitinib and/or belumosudil, unless contraindicated]
Reproductive & Pregnancy Management
- For females who can become pregnant: Pregnancy must be excluded prior to receiving axatilimab.
- For females who can become pregnant: Counseling provided on potential risks vs benefits of treatment and the use of effective contraception during therapy and for 30 days after stopping treatment.