Sumitomo Dainippon Pharma Announces the Approval of RETHIO for an Additional Indication of Conditioning Treatment Prior to Autologous Hematopoietic Stem Cell Transplantation for Malignant Lymphoma

Sumitomo Dainippon Pharma Co., Ltd. (Head Office: Osaka, Japan; Representative Director, President and CEO: Hiroshi Nomura hereinafter called “Sumitomo Dainippon Pharma”) announced today that, on March 25, 2020, it obtained approval for a partial change in the marketing approval previously acquired in Japan for RETHIO® 100 mg for I.V. infusion (generic name: thiotepa; hereinafter, “RETHIO®”). The change approved at this time involves an additional indication of RETHIO® for conditioning treatment prior to autologous hematopoietic stem cell transplantation (autoHSCT) for malignant lymphoma.
RETHIO® is a drug that Sumitomo Dainippon Pharma launched on May 28, 2019, for an indication of conditioning treatment prior to auto-HSCT for pediatric malignant solid tumors. Malignant lymphoma, which is related to this additional indication, is a type of hemocytes-derived cancer in which lymphocytes, a subpopulation of leukocytes (white blood cells) become cancerous, and typically occurs in lymphoid tissues, such as lymph nodes, spleens, and tonsils, but it often develops in other sites as well. It has been reported that 34,240 persons affected with this disease in FY2016*, making it the most common hematological malignancy in Japanese adults. As with conditioning treatment prior to auto-HSCT for pediatric malignant solid tumors, for which approval was received in 2019, the Evaluation Committee on Unapproved or Off-labeled Drugs with High Medical Needs of the Ministry of Health, Labour and Welfare (MHLW) determined similarly high medical need for thiotepa in conditioning treatment prior to auto-HSCT for malignant lymphoma. Accordingly, Sumitomo Dainippon Pharma conducted Phase 1 trials in Japan and subsequently applied for approval of the additional indication.
Sumitomo Dainippon Pharma believes that this approval will allow it to offer a new treatment option for malignant lymphoma patients who need conditioning treatment prior to auto-HSCT, a therapeutic area with a high unmet medical need, thus contributing to improved healthcare.
*Cancer Incidence of Japan 2016, Cancer and Disease Control Division, Health Service Bureau, MHLW

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