ZYNLONTA Granted Orphan Designation In Europe

Release Date: 06-Oct-2021

European Commission has granted Orphan Drug Designation to ZYNLONTAandreg;, a CD19-targeted ADC, for the treatment of diffuse large B-cell lymphoma (DLBCL). ZYNLONTAandreg; is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The effective payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This finally leads in cell cycle arrest and tumor cell death.


In past, US FDA approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma.


ZYNLONTA is being evaluated in combination for earlier lines of therapy and as a monotherapy in other B-cell malignancies. The most common adverse reactions (andge;20%) were thrombocytopenia, gamma-glutamyltransferase increased, neutropenia, anemia, hyperglycemia, transaminase elevation, fatigue, hypoalbuminemia, rash, edema, nausea and musculoskeletal pain. In LOTIS-2, the most common (andge;10%) grade andge;3 treatment-emergent adverse events were neutropenia (26.2%), thrombocytopenia (17.9%), gamma-glutamyltransferase increased (17.2%) and anemia (10.3%)

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