Full Press Release Details
Licensing partner, Tanabe Pharma, filed for Japanese approval of ZYNLONTA (MT-2111) for relapsed or refractory DLBCL based on encouraging Japanese Phase 1/2 clinical results
Tanabe Pharma entered into exclusive sublicensing agreement with Nippon Shinyaku, bringing established Japanese oncology expertise and commercial capabilities to support potential introduction in Japan
Supports anticipated regulatory and commercial milestones for ADC Therapeutics
LAUSANNE, Switzerland, Oct. 29, 2026 /PRNewswire/ -- ADC Therapeutics SA (NYSE: ADCT), a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), today announced 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.
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.
About ADC Therapeutics ADC Therapeutics (NYSE: ADCT) is a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), transforming treatment for patients through our focused portfolio with ZYNLONTA® (loncastuximab tesirine-lpyl).
ADC Therapeutics' CD19-directed ADC ZYNLONTA received accelerated approval by the FDA and conditional approval from the European Commission for the treatment of relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy. ZYNLONTA is also in development in combination with other agents and in earlier lines of therapy.
Headquartered in Lausanne (Biopôle), Switzerland, with operations in New Jersey, ADC Therapeutics is focused on driving innovation in ADC development with specialized capabilities from clinical to manufacturing and commercialization.
ZYNLONTA® is a registered trademark of ADC Therapeutics SA.
Forward-Looking Statements This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terminology such as "may", "will", "should", "would", "expect", "intend", "plan", "anticipate", "believe", "estimate", "predict", "potential", "seem", "seek", "future", "continue", or "appear" or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to: whether Tanabe's marketing authorization application filed with Japan's Ministry of Health for ZYNLONTA will be accepted, the timing and potential approval of the marketing authorization application for ZYNLONTA in Japan, the timing and payment of future regulatory and commercial milestones related to Japan, Nippon Shinyaku ability to successfully commercialize ZYNLONTA in Japan and the amount of future revenue in Japan and related payments to ADCT; the adequacy of the LOTIS-5 clinical trial data to support full regulatory approval and our ability to maintain accelerated approval in the United States and foreign jurisdictions for our product; our ability to identify and execute on potential regulatory and compendia pathways; the timing, content and outcome of meetings with and feedback or other communications provided by regulatory authorities including U.S. FDA including our ability to adequately address the serious concerns related to the LOTIS-5 trial results raised by the FDA at the recent pre-sBLA submission meeting; the timing, submission and outcome of an sBLA related to LOTIS-5 and potential approval; the actual and perceived benefit-risk profile for ZYNLONTA as studied in the LOTIS-5 trial; the assessment of the data from LOTIS-5 study, including additional analyses of outcomes observed for safety, efficacy and within key geographic regions and across certain patient sub-populations; the path for full regulatory approval for ZYNLONTA in the United States and foreign jurisdictions and into earlier lines of therapy; whether future LOTIS-7 results will be consistent with or different from the prior disclosure, the timing, results and publication of the full LOTIS-7 trial data and potential compendia inclusion; future regulatory strategy for a Phase 3 trial for the combination of ZYNLONTA plus glofitamab; our expected revenue growth in 2027 and the Company's ability to sustain or grow ZYNLONTA® revenue in the future; our expected cash runway into 2029; changes in our regulatory and commercial strategy; the ability of our partners to commercialize ZYNLONTA® in foreign markets, the timing and amount of future revenue and payments to us from such partnerships and their ability to obtain or maintain regulatory approval for ZYNLONTA® in foreign jurisdictions; the timing and results of the Company's clinical trials; the timing, publication and results of investigator-initiated trials including those studying FL and MZL and the potential regulatory and/or compendia strategy and the future opportunity; the timing and outcome of regulatory submissions for the Company's products or product candidates; actions by the FDA or foreign regulatory authorities; projected revenue and expenses; the Company's indebtedness, including HealthCare Royalty Management and Blue Owl and Oaktree facilities, and the restrictions imposed on the Company's activities by such indebtedness, the ability to comply with the terms of the various agreements and repay such indebtedness and the significant cash required to service such indebtedness; the Company's ability to obtain financial and other resources for its research, development, clinical, and commercial activities; uncertainties related to a potential change in domicile from Switzerland to Delaware, including the outcome of tax analyses associated with such redomiciliation, the receipt of requisite shareholder approval, and the ability to complete the redomiciliation on the anticipated terms and timeline, if at all; and the uncertainties of international trade policies, including tariffs, sanctions, trade barriers and most favored nation drug pricing and the potential impact they may have on our business, financial condition, and results of operations. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K and in the Company's other periodic and current reports and filings with the U.S. Securities and Exchange Commission. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this document.