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ADC Therapeutics files U.S. application for lonca in blood cancer

September 21, 2020

ADC Therapeutics (NYSE:ADCT) has submitted marketing application with FDA seeking approval for loncastuximab tesirine (Lonca) for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

The company says that the application is based on  efficacy and safety data from LOTIS 2 clinical trial. In June, the company announced interim data from LOTIS 2 study, demonstrating encouraging action.

Lonca (formerly ADCT-402) is an antibody drug conjugate composed of a humanized monoclonal antibody directed against human CD19.

Lonca is being evaluated in pivotal LOTIS 2 (Phase 2) trial in patients with relapsed or refractory DLBCL, LOTIS 3, a Phase 1/2 trial in combination with ibrutinib in patients with relapsed or refractory DLBCL or mantle cell lymphoma.

The company has also commenced LOTIS 5 (Phase 3) confirmatory trial of Lonca in combination with rituximab, which is intended to support a supplemental marketing application for Lonca to be used as a second-line therapy for the treatment of relapsed or refractory DLBCL.

https://seekingalpha.com/news/3615918-adc-therapeutics-files-u-s-application-for-lonca-in-blood-cancer

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