On October 29, 2026 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), reported that its Japanese licensing partner, Tanabe Pharma Corporation (formerly Mitsubishi Tanabe Pharma Corporation), filed a marketing authorization application with Japan’s Ministry of Health, Labor and Welfare on October 29, 2026, for ZYNLONTA (loncastuximab tesirine-lpyl) to treat patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. In addition, Tanabe Pharma has entered into an exclusive sublicensing agreement with Nippon Shinyaku Co., Ltd., for the commercialization of ZYNLONTA in Japan.
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Recently, encouraging results from the Phase 1/2 MT-2111-A-101 bridging study evaluating ZYNLONTA monotherapy in Japanese patients with relapsed or refractory DLBCL were presented at the Japanese Society of Hematology meeting. In the Phase 2 portion of the study in Japan, ZYNLONTA demonstrated an overall response rate of 58.1%, including a complete response rate of 41.9%, with median duration of response not reached at a median follow-up of 15.21 months. The findings were consistent with the pivotal LOTIS-2 global study, with no new safety concerns identified. Based on these results, Tanabe Pharma filed the marketing authorization application for ZYNLONTA in Japan.
"This is a significant step forward in our efforts to expand ZYNLONTA’s global reach to bring this important treatment option to more patients with B-cell malignancies," said Ameet Mallik, Chief Executive Officer of ADC Therapeutics. "Japan represents a meaningful opportunity for ZYNLONTA, and we’re encouraged by the progress our partners are making toward its potential introduction in this market. We look forward to building on this momentum as ZYNLONTA advances toward its next regulatory and commercial milestones."
Building on ADC Therapeutics’ exclusive licensing partnership with Tanabe Pharma established in 2022, Nippon Shinyaku will bring its established hematology/oncology commercial expertise to support ZYNLONTA’s potential introduction in Japan. Nippon Shinyaku has a strong commercial and field medical presence in Japan, with a track record of successfully introducing innovative therapies developed by global pharmaceutical companies to the Japanese market. Under the sublicensing agreement, Tanabe Pharma will remain responsible for ongoing development activities and for obtaining regulatory approval in Japan under the current application.
Under the existing license agreement between ADC Therapeutics and Tanabe Pharma as previously disclosed, near-term milestones include acceptance of filing a marketing authorization application for ZYNLONTA in the Tanabe Pharma territory for the treatment of DLBCL and the first commercial sale of ZYNLONTA in the Tanabe Pharma territory for the treatment of DLBCL.
(Press release, ADC Therapeutics, OCT 29, 2026, View Source [SID1234673966])