(Lymphoma) Tucidinostat Receives Japan Manufacturing and Marketing Approval

• July 5, 2021
• Reading time: 1 minute

On June 24, Meiji Seika Pharma Co., Ltd. announced that its partner company Huya Japan obtained Japan manufacturing and marketing approval on June 23 for the HDAC inhibitor tucidinostat, indicated for relapsed or refractory adult T-cell leukemia-lymphoma (ATL).

About Tucidinostat

Tucidinostat is an epigenetic immunomodulator — a benzamide-based oral drug that inhibits the enzymatic activity of HDAC1/2/3/10. It is believed that HDAC activity inhibition also suppresses histone deacetylation, inducing cell cycle arrest and apoptosis while inhibiting cell proliferation. Non-clinical study results suggest that in addition to inhibiting tumor cell proliferation, tucidinostat may also have immunomodulatory effects.

Approval Basis

The marketing approval was based on Phase 2b clinical trial results in Japanese patients with relapsed or refractory adult T-cell leukemia-lymphoma. The study was conducted by HUYABIO International, the parent company of Huya Japan, in partnership with Meiji Seika Pharma Co., Ltd.

Future Development

A variation application is currently being reviewed to expand the indication to include relapsed or refractory peripheral T-cell lymphoma (PTCL). The drug has been designated as an orphan drug for monotherapy treatment of PTCL and ATL. Phase 1/2 clinical trials are currently underway in the United States for tucidinostat in solid tumors.

Source: https://www.meiji-seika-pharma.co.jp/pressrelease/2021/detail/pdf/210624_01.pdf

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