Therapeutic Loncastuximab tesirine ADC from the original Zynlonta® commercial drug.
Product batch
| Expiry date
| Brand & Origin
| Price
| 1. Select quantity range | 2. Your quantity | |
|---|---|---|---|---|---|---|
2026.04 |
Zynlonta® DE |
1.392,00 €/mg
|
mg |
Evidentic’s analytical service includes a comprehensive array of methods to support the drug development process, including, for example, structure, aggregation, degree of isomerization and N-glycans identification of the active pharmaceutical ingredient (API).
Here you will find the product information for the reference product.
| Drug name | Zynlonta® |
| INN | Loncastuximab tesirine |
| API type | Loncastuximab tesirine is a CD19-directed antibody and alkylating agent conjugate, consisting of a humanised IgG1 kappa monoclonal antibody, produced in Chinese Hamster Ovary cells by recombinant DNA technology, and conjugated to SG3199, a pyrrolobenzodiazepine (PBD) dimer cytotoxic alkylating agent, through a protease-cleavable valine-alanine linker. SG3199 attached to the linker is designated as SG3249, also known as tesirine. |
| Pharmacotherapeutic group | Antineoplastic and immunomodulating agents, antineoplastic agents, monoclonal antibodies and antibody drug conjugates, other monoclonal antibodies and antibody drug conjugates |
| ATC code | L01FX22 |
| Target of antibody | CD19 |
| General function | |
| Short description | |
| Pharmacodynamic properties (Mechanism of action; Source EMA document) | Loncastuximab tesirine is an antibody-drug conjugate (ADC) targeting CD19. The monoclonal IgG1 kappa antibody component binds to human CD19, a transmembrane protein expressed on the surface of cells of B-lineage origin. The small molecule component is SG3199, a PBD dimer and alkylating agent. Upon binding to CD19, loncastuximab tesirine is internalised followed by release of SG3199 via proteolytic cleavage. The released SG3199 binds to the DNA minor groove and forms highly cytotoxic DNA interstrand crosslinks, subsequently inducing cell death. |
| Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document) | Higher loncastuximab tesirine exposure in Cycle 1 was associated with higher efficacy over the dose range of 0.015-0.2 mg/kg (0.1 to 1.33 times the maximum recommended dose). Higher loncastuximab tesirine exposure in Cycle 1 was associated with higher incidence of some Grade ≥2 adverse reactions, including skin and nail reactions, liver function test abnormalities and increased γ-glutamyltransferase. |
| Original license holder | |
| Marketing authorisation numbers | EU/1/22/1695/001 |
| Marketing authorisation holder | Swedish Orphan Biovitrum AB (publ) SE-112 76 Stockholm Sweden |
| Name of the manufacturer of the biological active substance | BSP Pharmaceuticals S.p.A Via Appia Km 65,561 04013 Latina Scalo (LT) Italy |
| Name and address of the manufacturer(s) responsible for batch release | Swedish Orphan Biovitrum AB (publ) Strandbergsgatan 49 SE-112 51 Stockholm Sweden |
| Max shelf life | Unopened vial 5 years 14 Reconstituted solution From a microbiological point of view, the reconstituted solution should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 4 hours refrigerated (2℃ - 8℃) or 4 hours at room temperature (20℃ - 25℃), unless reconstitution has taken place in controlled and validated aseptic conditions. Chemical and physical in-use stability of the reconstituted solution has been demonstrated for up to 4 hours refrigerated (2℃ - 8℃) or 4 hours at room temperature (20℃ - 25℃). Diluted solution From a microbiological point of view, the prepared solution for infusion should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours refrigerated (2℃ - 8℃) or 8 hours at room temperature (20℃ - 25℃), unless dilution has taken place in controlled and validated aseptic conditions. Chemical and physical in-use stability of the prepared solution for infusion has been demonstrated for up to 24 hours at room temperature (20℃ - 25℃). Do not use the medicinal product if the storage conditions exceed the limits. |
| Storage conditions | 2°C – 8°C |
| List of excipients | L-histidine L-histidine monohydrochloride Polysorbate 20 Sucrose |
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