Zynlonta

Large B-cell lymphoma — relapsed or refractory, after two or more lines of systemic therapy, including DLBCL NOS, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma

0.15 mg/kg IV every 3 weeks for 2 cycles, then 0.075 mg/kg every 3 weeks for subsequent cycles
Infuse over 30 minutes
Pre-medication (30 min before): Dexamethasone 4 mg IV or PO (Days 1-3 of each cycle to reduce edema and effusions)
Body weight cap: Use actual body weight; cap at 100 kg for dose calculation

For injection: 10 mg lyophilized powder in single-dose vial

None listed.

• Edema and Effusions: 37% (9% Grade ≥3). Including peripheral edema, pleural effusion, ascites, pericardial effusion. Pre-medicate with dexamethasone.
• Myelosuppression: Neutropenia 26% (Grade ≥3: 17%), thrombocytopenia 18% (Grade ≥3: 10%). Monitor CBC before each dose.
• Infections: 28% (Grade ≥3: 10%). Fatal infections reported.
• Cutaneous Reactions: Rash (30%), photosensitivity (6%), erythema multiforme. Avoid prolonged sun exposure. Use SPF 30+ sunscreen.
• Hepatotoxicity: GGT increase 22% (Grade ≥3: 8%). Monitor LFTs.
• Embryo-Fetal Toxicity

Thrombocytopenia (32%), neutropenia (26%), increased GGT (22%), fatigue (27%), rash (30%), edema (37%), nausea (23%), musculoskeletal pain (23%), infection (28%), diarrhea (12%), dyspnea (13%)

Edema/effusions (40%). Photosensitivity — UV avoidance required for 2 months. Myelosuppression: Grade 3+ neutropenia 32%, thrombocytopenia 28%. GGT elevation (52%).

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

Edema/effusions (40%). Photosensitivity — UV avoidance required for 2 months. Myelosuppression: Grade 3+ neutropenia 32%, thrombocytopenia 28%. GGT elevation (52%).

Consult the complete prescribing information for drug interactions, including effects on CYP enzymes, transporters, and concomitant medications that may require dose adjustments or monitoring.

Consult the full prescribing information for pregnancy-related considerations.

Refer to prescribing information for lactation guidance.

Pediatric safety and efficacy information is detailed in the full label.

Dose modifications for organ impairment are specified in the complete prescribing information.

Loncastuximab tesirine is an antibody-drug conjugate consisting of a humanized anti-CD19 IgG1 monoclonal antibody conjugated to a pyrrolobenzodiazepine (PBD) dimer cytotoxin (SG3199) via a cathepsin-cleavable valine-alanine linker. Upon binding CD19 on B cells and internalization, the PBD dimer is released and crosslinks DNA via the minor groove, blocking DNA replication and inducing cell death. PBDs are effective at extremely low concentrations.

ADC half-life: approximately 12 days. Payload (SG3199/PBD dimer) half-life: 6-10 days. Steady-state by Cycle 3. Clearance: 0.29 L/day. Vd: 7.5 L. PBD dimer binds in DNA minor groove forming interstrand crosslinks.

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

• LOTIS-2 — Loncastuximab tesirine in relapsed/refractory DLBCL after ≥2 prior lines. Phase II, n=145.
  🔬 NCT03589469 ↗ 📄 Primary Publication ↗

Zynlonta has FDA-approved indications across the following cancer types covered on PipelineEvidence: