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Tucidinostat received orphan drug designation in Japan for the treatment of R/R ATL

Sep 29, 2020

On September 28, 2020, tucidinostat (HBI-8000) received orphan drug designation by the Japanese Ministry of Health, Labour and Welfare (MHLW) as monotherapy for the treatment of relapsed or refractory (R/R) adult T-cell leukemia-lymphoma (ATL). 1This drug had already received orphan drug designation, in Japan, for the treatment of peripheral T-cell lymphoma (PTCL). 2

Tucidinostat is an orally bioavailable histone deacetylase (HDAC) inhibitor already approved for the treatment of lymphoma and metastatic breast cancer in  China . An ongoing phase IIb study is evaluating the safety and efficacy of tucidinostat in patients with R/R ATL ( NCT02955589 ). 1

ATL is endemic in  Japan, with 700 1,000 deaths reported each year. Unfortunately, few effective treatment options are available for patients with R/R aggressive ATL. The orphan drug designation of tucidinostat could help to address this unmet clinical need. 1

  1. PR Newswire. HUYA Bioscience International announces orphan drug designation for HBI-8000 monotherapy adult T-cell leukemia-lymphoma ATL in Japan. Published Sep 28, 2020. Accessed Sep 29, 2020.
  2. HUYA Bioscience International. HUYA Bioscience International announces orphan drug designation for HBI-8000 in Japan. Published Dec 22, 2015. Accessed Sep 29, 2020.