TAFASITAMAB-CXIX INJ
Clinical Criteria Summary
Document 639
Exclusion Criteria
- Absolute neutrophil count < 1500/µL or platelet count < 90,000/µL (if no bone marrow involvement)
- Total bilirubin > 2.5 times upper limit of normal (unless Gilbert’s syndrome or liver involvement)
- Alanine transaminase (ALT), aspartate transaminase (AST), and alkaline phosphatase > 3 times upper limit of normal (unless liver involvement)
- Creatinine clearance < 60 ml/min
- Unmanageable drug-drug interaction
- Not a candidate for concomitant lenalidomide therapy
- Contraindication to thromboprophylaxis while receiving tafasitamab and lenalidomide
- Pregnancy
- Lactating
Inclusion Criteria
- Previously treated, relapsed or refractory, diffuse large B-cell lymphoma in combination with lenalidomide
- Not eligible for autologous stem cell transplant
- Care is provided by a VA/VA Community Care oncology or hematology provider
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Goals of care and role of Palliative Care consult have been discussed and documented
Additional Inclusion Criteria
- 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.
Document 655
Indication & Disease State
- Relapsed or refractory diffuse large B-cell lymphoma (DLBCL)
Patient Eligibility & Treatment History
- Not eligible for autologous stem cell transplant (ASCT)
- Not a candidate for CAR T-cell therapy
- Relapsed/refractory DLBCL following 1–3 prior systemic therapies, including anti-CD20 monoclonal antibody (i.e., rituximab)
- Second-line (2L) treatment setting
Exclusions & Population Limitations
- Primary refractory DLBCL (i.e., fail to achieve a CR or relapse within 6 mos)
- Double or triple hit genetics (i.e., MYC, BCL2, and/or BCL6 translocations)
- Efficacy unknown in patients meeting the above exclusion criteria per L-MIND trial data
VA/NCCN Clinical Pathway & Guideline Recommendations
- Preferred 2L option (Category 2A) in combination with lenalidomide
- VA Oncology Clinical Pathway specifies use in the 2L setting for patients not eligible for ASCT and not a candidate for CAR T-cell therapy
- Unclear if anti-CD19-directed therapy could have a negative impact on efficacy of subsequent CAR T-cell therapy