Daiichi Sankyo peripheral T-cell lymphoma therapy approved in Japan [Yahoo! Finance]
DAIICHI SANKYO S/ADR (DSNKY)
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Company Research
Source: Yahoo! Finance
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. The trial assessed the efficacy and safety of EZHARMIA in patients with relapsed or refractory PTCL and adult T-cell leukemia/lymphoma who had previously undergone at least one systemic therapy and were ineligible for a hematopoietic stem cell transplant at screening. 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. In the study, EZHARMIA demonstrated an ORR of 43.7% in 119 efficacy-evaluable patients with
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