LONCASTUXIMAB TESIRINE-LPYL INJ
Clinical Criteria Summary
Document 632
Exclusion Criteria
- Absolute Neutrophil Count < 1000/µL
- Platelet count < 75,000/µL (if no bone marrow involvement)
- Total bilirubin > 1.5 times upper limit of normal (unless Gilbert’s syndrome or liver involvement)
- Alanine transaminase (ALT), aspartate transaminase (AST) and alkaline phosphatase > 2.5 times the upper limit of normal (unless liver involvement)
- Creatinine clearance < 60 ml/min
- Clinically significant third space fluid accumulation (e.g., ascites or pleural effusion requiring drainage)
- Bulky disease (tumor > 10 cm)
- Chronic or unresolved infection
- Unmanageable drug-drug interaction
- Pregnancy
- Lactating
Inclusion Criteria
- Relapsed or refractory, diffuse large B-cell lymphoma
- 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 0-2
- 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 10 months after stopping treatment.
Document 647
Indication & Approval Status
- Treatment of relapsed or refractory large B-cell lymphoma (R/R DLBCL) after > 2 lines of therapy (LOT)
- Includes DLBCL arising from low-grade lymphoma and high-grade B-cell lymphoma
- Granted accelerated approval based on overall response rate (ORR); continued approval is contingent on verification and description of clinical benefit in a confirmatory trial
Patient Population & Disease Characteristics
- Heavily pretreated population with R/R DLBCL following > 2 prior lines of therapy
- Includes patients with MYC and BCL2 and/or BCL6 rearrangements
- Applicable to advanced stage disease (stages III or IV)
Dosing & Administration
- Intravenous administration on day 1 of a 21-day cycle
- Cycles 1 and 2: 0.15 mg/kg
- Cycles 3 and beyond: 0.075 mg/kg
- Supplied as 10 mg loncastuximab lyophilized powder in a single-dose vial (SDV) for reconstitution and dilution
VA Clinical Pathway & Guideline Recommendations
- Not included in current VA Oncology Clinical Pathways for DLBCL, Relapsed, 2L
- Classified as an "Other recommended regimen (category 2A)" per NCCN guidelines for 3L and subsequent therapy
- Preferred regimens per NCCN include CAR T-cell therapy and BITE (epcoritamab, glofitamab)
- Remains an option if bispecific T-cell engagers are not available
Safety Monitoring & Warnings
- Monitor for effusion and edema
- Monitor for myelosuppression including neutropenia, thrombocytopenia, anemia, and febrile neutropenia (FN)
- Monitor for infections including sepsis and pneumonia
- Monitor for cutaneous reactions including photosensitivity
- Assess for embryo-fetal toxicity risks