Shots:
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
