Tanabe Pharma submitted an application in Japan for marketing approval of MT-2111, a treatment for relapsed or refractory DLBCL, and simultaneously entered into an exclusive sales sublicense agreement with Nihon Shinyaku.
On 29 October, Tanabe Pharma submitted a domestic marketing approval application to the Ministry of Health, Labour and Welfare for loncastuximab tesirine (MT-2111) for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL). On 22 October, it also entered into an exclusive sublicense agreement with Nihon Shinyaku for sales of the product in Japan.
The product is an anti-CD19 antibody-drug conjugate. It received accelerated approval from the U.S. FDA as monotherapy for patients with DLBCL who are negative for the stated condition after systemic therapy, and is being developed by ADC Therapeutics. Tanabe Pharma entered into a licensing agreement for development and commercialization in Japan in 2022, and the domestic application is based on the results of a clinical trial in Japanese patients with relapsed/refractory DLBCL.
With the domestic application, Tanabe Pharma has indicated a policy of promoting patient access to the product by using Nihon Shinyaku's expertise and business platform, with improvements in financial and strategic flexibility also expected. The domestic MT-2111-A-101 trial was conducted at multiple sites, and 43 patients were enrolled in its Phase 2 part.
MT-2111, whose generic name is loncastuximab tesirine-lpyl and whose ADC Therapeutics brand name is ZYNLONTA, has already received accelerated FDA approval for the treatment of DLBCL that has relapsed or become refractory after 2 or more systemic therapies. Conditional approval is progressing in the EU. Development in combination with other therapies is also under consideration.