(Lymphoma) FDA Grants Accelerated Approval to Zynlonta Monotherapy

On April 23, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Zynlonta (loncastuximab tesirine-lpyl) — a CD19-targeting antibody-alkylating agent conjugate — for adult patients with relapsed or refractory large B-cell lymphoma who have received two or more prior systemic therapies. The approval covers relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL), DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma.

The approval was based on the LOTIS-2 trial (NCT03589469), an open-label, single-arm study of 145 adult patients with relapsed or refractory DLBCL or high-grade B-cell lymphoma after at least two prior systemic therapies. Patients received Zynlonta 0.15 mg/kg every three weeks for two cycles, followed by 0.075 mg/kg every three weeks until disease progression or intolerable toxicity.

The primary endpoint ORR was 48.3%, with a complete response rate of 24.1%. Median follow-up was 7.3 months, and the median duration of response was 10.3 months. Among the 70 patients who achieved objective response, 36% had their response censored before three months.

The most common adverse events (≥20%) in patients receiving Zynlonta were thrombocytopenia, elevated gamma-GT, neutropenia, anemia, hyperglycemia, elevated transaminases, fatigue, hypoalbuminemia, rash, edema, nausea, and musculoskeletal pain.

The prescribing information includes warnings and precautions regarding edema, pleural effusion, myelosuppression, infections, and skin reactions.

The recommended dose of Zynlonta is 0.15 mg/kg every three weeks for two treatment cycles, followed by 0.075 mg/kg every three weeks thereafter. It is administered via intravenous infusion on Day 1 of each cycle. In addition, Dexamethasone 4 mg twice daily should be taken orally or administered intravenously for three consecutive days starting the day before each Zynlonta infusion.

Source: https://www.fda.gov/drugs/fda-grants-accelerated-approval-loncastuximab-tesirine-lpyl-large-b-cell-lymphoma

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