Daiichi Sankyo unveils Blood cancer drug EZHARMIA in Japan

Tokyo: Daiichi Sankyo has announced the launch of 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).

Marketing approval of EZHARMIA was granted by Japan's Ministry of Health, Labor and Welfare (MHLW) in September 2022 based on results of an open-label, single-arm pivotal phase 2 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."

EZHARMIA was generally well-tolerated in the phase 2 study.

Adult T-cell leukemia-lymphoma (abbreviated ATLL or ATL) is a rare and aggressive hematologic malignancy that is caused by human T-cell lymphotropic virus type 1 (HTLV-1). Incidence of ATLL is higher in regions where the HTLV-1 virus is endemic including southwest Japan, Central, and South America, Asia, central Australia, and Romania.2 Sporadic cases are observed in non-endemic regions 2 including North America and parts of Europe. Approximately 3,000 new cases of ATLL are diagnosed each year worldwide.3 In Japan, there are approximately 1,000 new ATLL cases and 1,000 deaths due to ATLL annually.