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Global First Approval For Daiichi’s EZH1/2 Inhibitor Valemetostat In Japan

Ozoralizumab Also Gets First Nod

 
• By Lisa Takagi

Japan has granted to the first approval worldwide to Daiichi Sankyo’s dual EZH1/2 inhibitor valemetostat, for the treatment of adult T-cell leukemia/lymphoma. Taisho’s trivalent anti-TNFα nanobody ozoralizumab also received its global first approval, as part a large new batch of regulatory nods in the country.

The First dual inhibitor for EZH 1/2 approved for ATL
First dual inhibitor for EZH 1/2 approved for ATL • Source: Shutterstock

Japan has given the first approval anywhere globally to Daiichi Sankyo Co., Ltd.’s dual inhibitor of EZH1 (enhancer of zeste homolog 1) and EZH2 Ezharmia (valemetostat; DS-3201), for the treatment of relapsed/refractory adult T-cell leukemia/lymphoma (ATL), putting it in a good position to be the first drug in the class to reach the market. 

It also marks another milestone for Daiichi's strategic pivot to oncology as a core focus, which has now resulted in the approval of five new drugs

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