来源: Pharmaceutical Technology
The asset previously received SAKIGAKE designation in Japan. Credit: Nemes Laszlo / Shutterstock.
EZHARMIA is the first dual EZH1 and EZH2 inhibitor to receive approval for this indication. The asset previously received the SAKIGAKE designation.
Its approval is grounded in the outcomes of the global, open-label, single-arm, two-cohort VALENTINE-PTCL01 Phase II trial.
来源: Pharmaceutical Technology
来源: Pharmaceutical Technology
It enrolled 133 patients across multiple sites in Europe, Asia, North America and Oceania,
The primary endpoint of the trial was objective response rate (ORR) with secondary endpoints being the duration of response, complete response (CR), partial response (PR), duration of CR, progression-free survival, overall survival, safety and pharmacokinetics.
Daiichi Sankyo Japan research and development division head and executive officer Toshinori Agatsuma stated: “This second indication for EZHARMIA in Japan is an important advance for the treatment of relapsed or refractory peripheral T-cell lymphoma, as new and effective treatment options are needed to improve patient outcomes. EZHARMIA exemplifies the innovative research being conducted by Daiichi Sankyo aimed at creating new medicines with the potential to change the standard of care for patients with cancer.”