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Overland ADCT BioPharma Announces Biologics License Application for ZYNLONTA®

Tuesday, July 25, 2023

Overland ADCT BioPharma, a joint venture of Overland Pharmaceuticals and ADC Therapeutics, has made significant progress with ZYNLONTA® (loncastuximab tesirine-lpyl) in China.

The China National Medical Products Administration (NMPA) has accepted the Biologics Licence Application (BLA) for ZYNLONTA®, which is seeking approval for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy in China.

ZYNLONTA® has already been approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. The approved indications include DLBCL not otherwise specified, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma.

The application was made based on the positive results from OL-ADCT-402-001, a Phase 2 bridging clinical trial for ZYNLONTA® in Chinese patients with r/r DLBCL. This study was designed to assess the efficacy and safety of ZYNLONTA® as a single-agent treatment for these patients.

 

Source: www.overlandpharma.com

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