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Today, ADC Therapeutics announced that the US FDA has accelerated the approval of the CD19-targeting antibody conjugate Zynlonta (loncastuximabtesirine-lpyl) as a single-drug treatment for adult patients with relapsed/refractory large B-cell lymphoma, these patients have at least received Two systemic therapies.
Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin’s lymphoma, and it is a rapidly progressing aggressive disease.
Antibody-conjugated drugs combine with specific antigens on the surface of cancer cells to deliver the toxic compounds carried into the cells, thereby killing cancer cells while avoiding damage to healthy cells.
▲Antibody conjugate drugs based on PBD dimers have a unique cytotoxic mechanism (picture source: ADC Therapeutics official website)
The FDA approval is based on a single-arm phase 2 clinical trial called LOTIS-2.
▲Zynlonta's disease remission data in phase 2 clinical trials (picture source: reference [2])
The latest data show that the median duration of remission for patients reached 12.
▲Remission duration data of Zynlonta in phase 2 clinical trials (picture source: reference [2])
"FDA approval of the listing of Zynlonta is an important advancement for DLBCL patients.
In China, according to the information on the website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China, the loncastuximab tesirine for injection jointly declared by ADC Therapeutics and Linglu Pharmaceuticals has obtained an implied license for a clinical trial and is expected to compete with Bruton’s The combination of kinase (BTK) inhibitors is used in clinical trials to treat patients with relapsed/refractory DBCLC or mantle cell lymphoma.
Reference materials:
[1] ADC Therapeutics Announces FDA Approval of ZYNLONTA™(loncastuximab tesirine-lpyl) in Relapsed or Refractory Diffuse Large B-CellLymphoma.
[2] ADC Therapeutics Corporate Presentation.
Note: This article aims to introduce the progress of medical and health research, not to recommend treatment options.
