Swedish Orphan Biovitrum — Zynlonta EMA EPAR public assessment report (EMEA/H/C/005685, 2022)
Swedish Orphan Biovitrum · 2022 · EMA EPAR public assessment report
Report summary
This EMA report assesses Zynlonta (loncastuximab tesirine) for relapsed/refractory diffuse large B-cell lymphoma (DLBCL), leading to conditional marketing authorization. Zynlonta, an antibody-drug conjugate, addresses a significant unmet medical need. The report details its quality, manufacturing, non-clinical pharmacology, and toxicology. Clinical studies (ADCT-402-101 and ADCT-402-201) demonstrated an overall response rate of 48.3% and a median duration of response of 13.37 months in heavily pre-treated patients. The report also covers exposure-response relationships and a comprehensive safety profile, including common and serious adverse events. A confirmatory Phase 3 study (LOTIS-5) is ongoing.
Key findings — cited to the page
| fatigue (Grade 3 or higher) | 2.3 % | loncastuximab tesirine monotherapy · p.118 |
| thrombocytopenia (Grade 3 or higher) | 15.8 % | loncastuximab tesirine monotherapy · p.113 |
| neutrophil count decreased (Grade 3 or higher) | 3.3 % | loncastuximab tesirine monotherapy · p.113 |
| patients with any Related TEAE of Grade ≥ 3 | 110 % | loncastuximab tesirine monotherapy · p.109 |
| neutropenia (Grade 3 or higher) | 24.2 % | loncastuximab tesirine monotherapy · p.113 |
| GGT increased (Grade 3 or higher) | 17.2 % | loncastuximab tesirine monotherapy · p.113 |
| patients with any Grade 3 or higher related TEAE | 110 % | loncastuximab tesirine monotherapy · p.110 |
| anaemia (Grade 3 or higher) | 11.6 % | loncastuximab tesirine monotherapy · p.113 |
| patients with any Grade 3 or higher TEAE | 160 % | loncastuximab tesirine monotherapy · p.107 |
| patients with any TEAE of Grade ≥ 3 | 160 % | loncastuximab tesirine monotherapy · p.109 |
| patients with any TEAE of Grade ≥ 3 | 160 % | loncastuximab tesirine monotherapy · p.112 |
| LFT Grade 3 events | 17.7 % | loncastuximab tesirine monotherapy · p.118 |
Source: Swedish Orphan Biovitrum ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →