loncastuximab tesirine
Drug Details
- Generic Name
- loncastuximab tesirine
- Brand Names
- ZYNLONTA
- Application Number
- BLA761196
- Sponsor
- ADC Therapeutics America, Inc.
- NDC Codes
- 1
- Dosage Forms
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Routes
- INTRAVENOUS
- Active Ingredients
- LONCASTUXIMAB TESIRINE
Indications and Usage
1 INDICATIONS AND USAGE ZYNLONTA is indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more 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. This indication is approved under accelerated approval based on overall response rate [see Clinical Studies (14.1) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ZYNLONTA is a CD19-directed antibody and alkylating agent conjugate indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more 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. ( 1 ) This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1 )