United States - English - NLM (National Library of Medicine)

adc therapeutics america, inc. - loncastuximab tesirine (unii: 7k5o7p6qiu) (loncastuximab tesirine - unii:7k5o7p6qiu) - zynlonta is indicated for the treatment of adult patients with relapsed or refractory large b-cell lymphoma after two or more lines of systemic therapy, including diffuse large b-cell lymphoma (dlbcl) not otherwise specified, dlbcl arising from low-grade lymphoma, and high-grade b-cell lymphoma. this indication is approved under accelerated approval based on overall response rate [see clinical studies (14.1)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). none risk summary based on its mechanism of action, zynlonta can cause embryo-fetal harm when administered to a pregnant woman, because it contains a genotoxic compound (sg3199) and affects actively dividing cells [see clinical pharmacology (12.1) and nonclinical toxicology (13.1)] . there are no available data on the use of zynlonta in pregnant women to evaluate for drug-associated risk. no animal reproduction studies were conducted with zynlonta. advise pregnant

European Union - English - EMA (European Medicines Agency)

swedish orphan biovitrum ab - loncastuximab tesirine - lymphoma, large b-cell, diffuse; lymphoma, b-cell - antineoplastic agents - zynlonta as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large b-cell lymphoma (dlbcl) and high-grade b-cell lymphoma (hgbl), after two or more lines of systemic therapy.