Dual EZH1 and EZH2 inhibitor Ezharmia launched in Japan

Japan’s Daiichi Sankyo (TYO: 4568) today announced it has launched Ezharmia (valemetostat tosilate), a first-in-class dual inhibitor of EZH1 and EZH2, in Japan for the treatment of patients with relapsed or refractory adult T-cell leukemia-lymphoma (ATLL).

The Japanese Ministry of Health, Labor and Welfare (MHLW) approved Ezharmia September 2022 based on results of an open-label, single-arm pivotal Phase II study in 25 patients with three aggressive subtypes of relapsed or refractory ATLL in Japan. Data from the trial demonstrated an objective response rate (ORR) of 48% (95% CI: 27.8%-68.7%).

“Patients in Japan with relapsed or refractory adult T-cell leukemia-lymphoma, who have had limited treatment options beyond intensive chemotherapy, now have access to Ezharmia, the first dual inhibitor of EZH1 and EZH2 to be approved for treatment of ATLL,” said Yoshinori Kaneshima, corporate officer, head of marketing division, Japan Business Unit, Daiichi Sankyo. “Ezharmia is a new and novel therapy discovered by Daiichi Sankyo and is the fifth innovative oncology medicine we have launched in Japan in the past three years.”