Loncastuximab tesirine
Highest phase reached
Approved
Drug type
Antibody drug conjugate
First approval year
2021
- First approval year
- 2021
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody drug conjugate
- Drug name
- Loncastuximab tesirine
- zynlonta
- Zynlonta
- adct 402
- adct 402 tesirine
- ADCT-402
- Adct-402 tesirine
- ADCT-402 TESIRINE
- loncastuximab tesirina
- Loncastuximab tesirina
- loncastuximab tesirine
- Loncastuximab tesirine
- Loncastuximab Tesirine
- loncastuximab tesirine [INN]
- Loncastuximab tesirine [MI]
- LONCASTUXIMAB TESIRINE [USAN]
- Loncastuximab tesirine [WHO-DD]
- loncastuximab tesirine inn
- loncastuximab tesirine lpyl
- Loncastuximab tesirine lpyl
- Loncastuximab tesirine lpyl [WHO-DD]
- loncastuximab tesirine lpyl who dd
- loncastuximab tesirine mi
- loncastuximab tesirine usan
- loncastuximab tesirine who dd
- Loncastuximab tesirine-lpyl
- ATC classification codes
- L01FX22
Sources for recorded values
- CAS registry numbers
- 1879918-31-6
- ChEMBL ID
- CHEMBL4297778
- FDA ingredient codes (UNII)
- 7K5O7P6QIU
- 2540964
- 2540965
- Applicant
- ADC Therapeutics SA
- Approval date
- 23 Apr 2021
- Application number
- BLA761196
- Status
- Authorised
- Status date
- 20 Dec 2022
- Authorisation date
- 20 Dec 2022
- Approved indications
- 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.
- Product number
- EMEA/H/C/005685
- Authorisation holder
- Swedish Orphan Biovitrum AB
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- Yes
- Additional monitoring
- Yes
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Lymphoma, B-Cell
- Lymphoma, Large B-Cell, Diffuse
European medicines record
- Patents
- 0
- Designations
- 3
- Earliest recorded loss of exclusivity
- 23 Apr 2028
- First in class
- Yes
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- Yes
- Availability
- Prescription only
- Pharmacology name
- loncastuximab tesirine
- Type
- Antibody
- Drug name stem
- -mab
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Mechanism
- B-lymphocyte antigen CD19 binding agent
- Action type
- BINDING_AGENT
- Target
- B-lymphocyte antigen CD19
- Protein identifier
- P15391
- Action
- Binding
- Action type
- Binding
- Target
- CD19
- Gene symbol
- CD19
- Protein identifier
- P15391
- Mechanism
- DNA cross-linking agent
- Action type
- CROSS_LINKING_AGENT
- Target
- DNA
Open Targets mechanisms
- Mechanism
- B-lymphocyte antigen CD19 binding agent
- Action type
- BINDING AGENT
- Target
- B-lymphocyte antigen CD19
- Condition
- Leukemia, Lymphocytic, Chronic, B-Cell
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000095
- Subject identifier
- D015451
- Condition
- Lymphoma, Follicular
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000096
- Subject identifier
- D008224
- Condition
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000220
- Subject identifier
- D054198
- Condition
- Burkitt Lymphoma
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000309
- Subject identifier
- D002051
- Condition
- Lymphoma, Large B-Cell, Diffuse
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000403
- Subject identifier
- D016403
- Condition
- Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- Lymphoma, Non-Hodgkin
- Highest recorded phase
- 2
- Condition identifier
- EFO:0005952
- Subject identifier
- D008228
- Condition
- Waldenstrom Macroglobulinemia
- Highest recorded phase
- 2
- Condition identifier
- EFO:0009441
- Subject identifier
- D008258
- Condition
- Lymphoma, Mantle-Cell
- Highest recorded phase
- 2
- Condition identifier
- EFO:1001469
- Subject identifier
- D020522
- Condition
- Lymphoma, B-Cell
- Highest recorded phase
- 4
- Condition identifier
- EFO:1001938
- Subject identifier
- D016393
- Condition
- Lymphoma, B-Cell
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0004095
- Subject identifier
- D016393
- Condition
- Lymphoma, Follicular
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0018906
- Subject identifier
- D008224
- Condition identifier
- EFO_0000095
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000096
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000220
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000403
- Condition identifier
- EFO_0000616
- Condition identifier
- EFO_0005952
- Highest recorded phase
- 1
- Condition identifier
- EFO_1001938
- Condition identifier
- MONDO_0002571
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0004095
- Condition identifier
- MONDO_0004095
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0004948
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0004967
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0005062
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005070
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0007243
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0015759
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0017604
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0018876
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0018905
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0018906
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0018908
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0019088
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0044889
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0100280
- Highest recorded phase
- 2
- NCT02669264
- NCT03589469
- NCT04384484
- NCT04974996
- NCT05144009
- NCT05222438
- NCT05464719
- NCT04970901
- NCT05270057
- NCT04699461
- NCT04998669
- NCT05053659
- NCT05991388
- NCT05190705
- NCT05249959
- NCT05971251
- Dose
- 0.15 mg/kg
- Route
- Intravenous
- How often
- Every 3 weeks
- Administer as an infusion over 30 minutes.
- Do not mix with or administer with other drugs.
- Premedicate with dexamethasone 4 mg orally or intravenously twice daily for 3 days starting the day before ZYNLONTA.
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Heavy chain
- Type
- Protein
- Sequence
- QVQLVQPGAEVVKPGASVKLSCKTSGYTFTSNWMHWVKQAPGQGLEWIGEIDPSDSYTNYNQNFQGKAKLTVDKSTSTAYMEVSSLRSDDTAVYYCARGSNPYYYAMDYWGQGTSVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPG
- Component
- Light chain
- Type
- Protein
- Sequence
- EIVLTQSPAIMSASPGERVTMTCSASSGVNYMHWYQQKPGTSPRRWIYDTSKLASGVPARFSGSGSGTSYSLTISSMEPEDAATYYCHQRGSYTFGGGTKLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC1
- Component
- Disulfide bridges location
- Sequence
- 22-96$22''-96''$23'-87'$23'''-87'''$131'-191'$131'''-191'''$147-203$147''-203''$211'-223$211'''-223''$229-229''$232-232''$264-324$264''-324''$370-428$370''-428''
- 79952-110
Related records
Trials (30)
- A Global Study of Novel Agents in Paediatric and Adolescent Relapsed and Refractory B-cell Non-Hodgkin Lymphoma
- A Phase II Study of Loncastuximab Tesirine as Consolidation Strategy in Patients With LBCL in PR After CAR T-cell Therapy
- A Study of Loncastuximab Tesirine and Rituximab (Lonca-R) in Previously Untreated Unfit/Frail Participants With Diffuse Large B-cell Lymphoma (DLBCL)
- A Study to Evaluate the Pharmacokinetics and Safety of Loncastuximab Tesirine in Participants With Relapsed or Refractory Diffuse Large B-cell Lymphoma or High-grade B-cell Lymphoma With Hepatic Impairment (LOTIS-10)
- A Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination With Other Anti-cancer Agents in Participants With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7)
- A Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Antitumor Activity of Loncastuximab Tesirine in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Previously Untreated Diffuse Large B-cell Lymphoma (LOTIS-8)
- Addition of Loncastuximab Tesirine to Acalbrutinib , Chronic Lymphocytic Leukemia
- Combining Loncastuximab Tesirine and Epcoritamab in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)
- Consolidation With Loncastuximab Tesirine After a Short Course of Immunochemotherapy in BTKi-treated (or Intolerant) Relapsed/Refractory Mantle Cell Lymphoma Patients.
- Epcoritamab in Combination With Loncastuximab Tesirine in Relapsed/Refractory Large B-cell Lymphoma
- Loncastixumab Tesirine (ADCT-402) Expanded Access Program (EAP) for Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
- Loncastuximab Tesirine and Mosunetuzumab for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma
- Loncastuximab Tesirine and Rituximab as Bridging Therapy Before Standard-of-care CAR-T Therapy in Patients With Large B-cell Lymphoma (CORAL)
- Loncastuximab Tesirine and Rituximab as First-line Therapy in Patients With Post-transplant Lymphoproliferative Disorder (PLUTO)
- Loncastuximab Tesirine and Rituximab Followed by DA-EPOCH-R for Treating Patients With High-Risk Diffuse Large B-cell Lymphoma
- Loncastuximab Tesirine and Rituximab Following Stereotactic Radiosurgery in Patients With Central Nervous System Lymphomas (SOLAR)
- Loncastuximab Tesirine and Venetoclax for Relapsed/ Refractory Non-Hodgkin Lymphoma
- Loncastuximab Tesirine for the Treatment of Relapsed or Refractory B-Cell Malignancies
- Loncastuximab Tesirine in Combination With Chemotherapy Prior to Stem Cell Transplant for the Treatment of Recurrent or Refractory Diffuse Large B-Cell Lymphoma
- Loncastuximab Tesirine in Combination With DA-EPOCH-R in Patients With Previously Untreated Aggressive B-cell Lymphoid Malignancies
Approved for (4)
In development for (8)
- Acute lymphoblastic leukemia Phase 1
- B-cell chronic lymphocytic leukemia Phase 1
- Burkitt lymphoma Phase 1
- Follicular lymphoma Phase 2
- Mantle cell lymphoma Phase 2
- Neoplasm of mature B-cells Phase 2
- Non-Hodgkin lymphoma Phase 2
- Waldenstrom macroglobulinemia Phase 2
Targets (1)
- CD19 B-lymphocyte antigen CD19 binding agent