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Daiichi Sankyo’s Ezharmia (valemetostat tosilate) Receives MHLW Approval for the Treatment of T-Cell Leukemia/ Lymphoma in Japan

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Daiichi Sankyo’s Ezharmia (valemetostat tosilate) Receives MHLW Approval for the Treatment of T-Cell Leukemia/ Lymphoma in Japan

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  • The approval was based on the P-II study evaluating Ezharmia (200mg, qd) in 25 patients with 3 aggressive subtypes of r/rATL prior treated with mogamulizumab or 1 systemic CT in case of intolerance/ contraindication for mogamulizumab and with no history of Allo-HSCT
  • The results showed 48% ORR as evaluated by an independent efficacy assessment committee, CR (20%) & PR (28%), were generally well-tolerated, and drug-related TEAEs were reported in 96% of patients
  • Ezharmia is a dual inhibitor of EZH1 & EZH2 that is currently under clinical development for multiple types of non-Hodgkin lymphoma. The therapy has received ODD from the US FDA for PTCL in Dec 2021 & from MHLW for r/r ATL in Nov 2021

Ref: Daiichi Sankyo | Image: Daiichi Sankyo

 

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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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