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Tucidinostat received orphan drug designation in Japan for the treatment of R/R ATL
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).1 This 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
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