Daiichi Sankyo has announced approval from the Japan Ministry of Health, Labour and Welfare for EZHARMIA (valemetostat tosilate) to treat relapsed or refractory (r/r) peripheral T-cell lymphoma (PTCL).

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 relapsed or refractory PTCL.

The treatment also led to 17 CRs and 35 PRs, with responses observed across various PTCL subtypes, including angioimmunoblastic T-cell lymphoma, PTCL not otherwise specified and other PTCL subtypes.

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.”