Overview
Relapsed and refractory B-cell acute lymphoblastic leukemia (B-ALL) are a therapeutic challenge for patients who have undergone prior systemic therapies with limited success. Prognosis is poor and more effective therapies are needed to treat relapsed/refractory cases and improve survival. On April 23 2021, the Food and Drug Administration granted accelerated approval for the antibody-drug conjugate, loncastuximab tesirine-lpyl, also known as Zynlonta. Zylonta also received approval in the EU on December 22, 2022. This therapy was developed by ADC Therapeutics and its accelerated approval for relapsed or refractory B-cell lymphoma is based on promising results from the LOTIS-2 clinical trial.
Indication
Loncastuximab tesirine is indicated for the treatment of adults with relapsed or refractory large B-cell lymphoma who have undergone two or more prior 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. The above indication is approved under accelerated FDA approval following the results of clinical studies. Continued approval is dependant upon the results of confirmatory clinical trials. In Europe, Loncastuximab tesirine is approved for treatment of both adult and pediatric patients aged 12 years old or older for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) after two or more lines of systemic therapy.
Associated Conditions
- Refractory Diffuse Large B Cell Lymphoma (DLBCL)
- Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
- Relapsed Diffuse Large B-cell Lymphoma (DLBCL)
- Refractory High Grade B-cell Lymphoma (HGBCL)
- Relapsed Diffuse large B-cell lymphoma NOS
- Relapsed High Grade B-cell Lymphoma (HGBCL)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/04/09 | Phase 2 | Not yet recruiting | |||
2025/01/23 | Phase 2 | Recruiting | |||
2023/08/14 | Phase 2 | Recruiting | |||
2023/01/05 | Phase 2 | Recruiting | City of Hope Medical Center | ||
2022/12/21 | Phase 1 | Recruiting | |||
2022/12/20 | Phase 1 | Active, not recruiting | |||
2022/07/19 | Phase 2 | Recruiting | |||
2022/07/12 | Phase 2 | Recruiting | |||
2022/02/03 | Phase 2 | Withdrawn | |||
2022/01/13 | Phase 2 | Recruiting | Shayna Sarosiek, MD |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| ADC Therapeutics America, Inc. | 79952-110 | INTRAVENOUS | 10 mg in 2 mL | 10/19/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 12/20/2022 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| ZYNLONTA® FOR INJECTION 10MG/VIAL | SIN17098P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 10mg/vial | 9/25/2024 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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