Oncology Drug Reference Sheet: Loncastuximab Tesirine-Lpyl
Based on LOTIS-2 trial results that reported an overall response rate of nearly 50%, in April 2021 the U.S. Food and Drug Administration granted accelerated approval (https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-loncastuximab-tesirine-lpyl-large-b-cell-lymphoma) to loncastuximab tesirine-lpyl (https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761196s000lbl.pdf) (ZynlontaTM) for adults with relapsed or refractory large B-cell lymphoma.
CD19-directed antibody and alkylating agent conjugate (ADC Therapeutics America, 2021)
Mechanism of Action
The monoclonal IgG1 kappa antibody component binds to CD19 expressed on the surface of cells of B-lineage. Once bound to CD19, loncastuximab tesirine-lpyl is internalized and releases the small molecule component SG3199, which subsequently induces cell death.
Adults with relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma, who have received two or more lines of systemic therapy
0.15 mg/kg every three weeks for two cycles, then 0.075 mg/kg every three weeks for subsequent cycles
Administer via a dedicated IV line with a sterile, non-pyrogenic, low-protein binding in-line or add-on filter (0.2- or 0.22-micron pore size) over 30 minutes on day 1 of each three-week cycle. Premedicate with dexamethasone 4 mg orally or via IV twice daily for three days beginning the day before loncastuximab tesirine-lpyl is administered.
In clinical trials, more than 20% of patients experienced fatigue, rash, edema, nausea, musculoskeletal pain, thrombocytopenia, increased gamma-glutamyltransferase, neutropenia, anemia, hyperglycemia, and transaminase elevation.
The prescribing information contains warnings for effusion and edema (i.e., pleural effusion, pericardial effusion, ascites, peripheral edema, and general edema), myelosuppression, infection (most commonly sepsis and pneumonia), cutaneous reactions, and embryo-fetal toxicity.
Refer to the package insert for dose delay or modification criteria. Monitor patients closely for new or worsening edema or effusions, and monitor complete blood counts throughout treatment. Cutaneous reactions, including photosensitivity, can occur; instruct patients to protect their skin from the sun.
Report any new or worsening dyspnea, chest pain, or ascites. Watch for signs of infection. Avoid or minimize exposure to direct natural or artificial sunlight, including through glass windows, and protect your skin by wearing sun-protective clothing or sunscreen. If you are a female of reproductive potential, use effective contraception during and for nine months after your final treatment; if you are a male with a female partner of reproductive potential, use effective contraception during and for six months after your final treatment. Avoid breastfeeding during treatment and for three months after the last dose.
Special Population Considerations
No significant differences in safety or efficacy were observed between patients aged 65 or older and younger patients in clinical trials. Safety and efficacy have not been established among pediatric patients.
Loncastuximab tesirine-lpyl is a hazardous drug; follow safe handling and disposal procedures.
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