The Center for Drug Evaluation (CDE) in China has indicated that Overland ADCT BioPharma (CY) Ltd’s Zynlonta (loncastuximab tesirine), an antibody-drug conjugate (ADC) targeting CD19, and BeiGene Ltd’s (NASDAQ: BGNE, HKG: 6160, SHA: 688235) Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib) are on track to receive priority review statuses. Both drugs are being considered for conditional approvals, with indications for the treatment of recurrent/refractory diffuse large B-cell lymphoma (R/R DLBCL) and recurrent or refractory follicular lymphoma (FL) in patients who have undergone at least second-line systemic therapy, including obinutuzumab.
Zynlonta’s Global Approvals and Potential for China
Zynlonta received fast-track approval in the US in April 2021, marking it as the first of its kind worldwide for use in R/R DLBCL that has received at least two lines of prior systemic therapy. It later earned conditional approval in the European Union (EU) in December of the same year. Overland ADCT BioPharma (CY) Ltd, a joint venture between China’s Overland Pharmaceuticals and Swiss firm ADC Therapeutics SA (NYSE: ADCT), is responsible for the development and commercialization of Zynlonta and other ADCs in Greater China. Taiwan-based Orient EuroPharma Co., Ltd has obtained exclusive agency rights to the drug in Taiwan and Singapore. Positive results from the Phase II regulatory OL-ADCT-402-001 study for Zynlonta in R/R DLBCL have allowed Overland ADCT to file for marketing approval in China.
Brukinsa’s Expanded Indications and Regulatory Milestones
Brukinsa is already approved in the US for a range of indications, including Waldenstrom’s macroglobulinemia (WM), mantle-cell lymphoma (MCL), and marginal zone lymphoma (MZL). The FDA had delayed the PDUFA for the drug to fully review additional data provided, including the eventual remission evaluation results of the ALPINE study. Brukinsa was first approved in the United States in November 2019 to treat MCL in previously treated adult patients. In China, Brukinsa was approved in June 2020 for both MCL and for previously treated adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Regulatory approvals were updated in May 2023, with two new indication approvals: newly diagnosed CLL or SLL and newly diagnosed WM.-Fineline Info & Tech
