ADC Therapeutics SA (NYSE:ADCT) announced on October 29, 2026, that its Japanese licensing partner Tanabe Pharma Corporation filed a marketing authorization application with Japan's Ministry of Health, Labor and Welfare for ZYNLONTA (loncastuximab tesirine-lpyl) to treat relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy.

Key Highlights

  • Filing date: Tanabe Pharma submitted the marketing authorization application in Japan on October 29, 2026.
  • Target indication: Relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.
  • Phase 2 Japan data: ZYNLONTA showed an overall response rate of 58.1% and a complete response rate of 41.9% in the Japanese bridging study, with median duration of response not reached at a median follow-up of 15.21 months.
  • New sublicense: Tanabe Pharma entered into an exclusive sublicensing agreement with Nippon Shinyaku Co., Ltd. for commercialization of ZYNLONTA in Japan.
  • Roles under sublicense: Tanabe Pharma retains responsibility for ongoing development and regulatory approval; Nippon Shinyaku will support commercialization.
  • Milestones noted: Near-term milestones under the existing license agreement include acceptance of the marketing authorization application filing and the first commercial sale of ZYNLONTA in Japan for DLBCL.

Tanabe Pharma's Japan Application and Nippon Shinyaku Sublicense

According to the filing, Tanabe Pharma Corporation (formerly Mitsubishi Tanabe Pharma Corporation) submitted a marketing authorization application to Japan's Ministry of Health, Labor and Welfare on October 29, 2026, seeking approval of ZYNLONTA for patients with relapsed or refractory DLBCL who have received two or more prior lines of systemic therapy. The application was supported by results from the Phase 1/2 MT-2111-A-101 bridging study, which were presented at the Japanese Society of Hematology meeting, the company disclosed.

In the Phase 2 portion of that Japanese study, ADC Therapeutics reported that ZYNLONTA monotherapy 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 company stated the findings were "consistent with the pivotal LOTIS-2 global study, with no new safety concerns identified." The existing license agreement between ADC Therapeutics and Tanabe Pharma was established in 2022, according to the filing.

Separately, Tanabe Pharma entered into an exclusive sublicensing agreement with Nippon Shinyaku Co., Ltd. to support potential commercialization of ZYNLONTA in Japan. The filing states that 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 arrangement, Tanabe Pharma will remain responsible for development activities and for obtaining regulatory approval under the current application. The company noted that near-term milestones under the existing license agreement include acceptance of the marketing authorization application filing and the first commercial sale of ZYNLONTA in Japan for DLBCL. The filing also includes forward-looking statements, which the company cautions are subject to risks including whether the application will be accepted, the timing and potential approval, and Nippon Shinyaku's ability to successfully commercialize ZYNLONTA in Japan.

What Was Disclosed

ADC Therapeutics disclosed that Tanabe Pharma filed a Japanese marketing authorization application for ZYNLONTA on October 29, 2026, underpinned by Phase 2 Japan bridging study data, and that Tanabe Pharma simultaneously entered into an exclusive sublicensing agreement with Nippon Shinyaku for Japanese commercialization.