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Daiichi Sankyo Reports Submission of NDA to MHLW for Valemetostat to Treat T-Cell Leukemia/Lymphoma

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Daiichi Sankyo Reports Submission of NDA to MHLW for Valemetostat to Treat T-Cell Leukemia/Lymphoma

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  • The submission is based on the P-II study to evaluate the efficacy and safety of valemetostat (200mg, qd)) as monothx. in 25 patients with r/r ATL prior treated with mogamulizumab or at least one systemic CT in case of intolerance/ contraindication for mogamulizumab
  • The 1EPs is ORR as assessed by independent efficacy assessment committee & 2EPs include investigator-assessed ORR, best response in tumor lesions, CRR, TCR, time to response, DoR, PFS, OS & safety
  • Valemetostat is a dual inhibitor of EZH1 and EZH2 & is currently in clinical development in the Alpha portfolio of Daiichi Sankyo. The therapy has received ODD from the MHLW for r/r ATL

Ref: Businesswire | Image: Daiichi Sankyo

Click here to­ read the full press release 

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