Pharma Focus Europe

Overland ADCT Biopharma's ZYNLONTA® Receives Priority Review From NMPA for Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma

Tuesday, July 25, 2023

Overland ADCT BioPharma has made a significant announcement regarding their drug, ZYNLONTA® (loncastuximab tesirine-lpyl), in China. The China National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for ZYNLONTA, seeking approval for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) who have undergone two or more lines of systemic therapy in China. The NMPA has granted priority review status to the BLA, expediting the evaluation process.

The BLA submission is based on the positive results from OL-ADCT-402-001, a Phase 2 clinical trial conducted for ZYNLONTA in Chinese patients with r/r DLBCL. The study aimed to assess the drug's efficacy and safety as a single-agent treatment for this patient population.

Professor Zhu Jun, principal investigator of the OL-ADCT-402-001 study and a key figure at Beijing Cancer Hospital, expressed the urgent need for safer and more effective treatments for r/r DLBCL patients in China. He hopes that ZYNLONTA will soon become available to these patients, potentially addressing their unmet medical needs.

Ameet Mallik, the Chief Executive Officer of ADC Therapeutics, expressed satisfaction with the rapid progress of ZYNLONTA's development program in China. The acceptance of the BLA and the priority review designation mark significant steps forward in their commitment to providing ZYNLONTA to patients worldwide.

Ed Zhang, Co-founder and CEO of Overland Pharmaceuticals, expressed his excitement about reaching this meaningful milestone. The partnership between Overland Pharmaceuticals and ADC Therapeutics began in December 2020, and they have achieved substantial progress, completing the clinical study and submitting the first BLA within two and a half years. Zhang extended his gratitude to the participating patients, clinical investigators, health authorities, and ADC Therapeutics for their unwavering support, emphasizing their dedication to maximizing the potential benefits of ZYNLONTA for Chinese patients.

Overland ADCT BioPharma holds the exclusive rights to develop and commercialize ZYNLONTA in Greater China and Singapore. The BLAs for ZYNLONTA have already been submitted in Singapore, Hong Kong, and Taiwan, indicating their commitment to addressing the unmet needs of r/r DLBCL patients across these regions.

ZYNLONTA has received approval from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency for the treatment of adult patients with r/r large B-cell lymphoma after two or more lines of systemic therapy, including various DLBCL subtypes. This approval was based on overall response rate, and continued approval for this indication may depend on clinical benefit verification in a confirmatory trial.

https://www.globenewswire.com/news-release/2023/07/24/2709420/0/en/Overland-ADCT-BioPharma-Announces-NMPA-Accepts-Biologics-License-Application-and-Grants-Priority-Review-for-ZYNLONTA-for-Treatment-of-Relapsed-or-Refractory-Diffuse-Large-B-cell-Ly.html

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