Words by GOLD newsdesk
In a first for the pharmaceutical industry, Daiichi Sankyo has obtained Japanese approval for Ezharmia to treat relapsed or refractory adult T-cell leukaemia/lymphoma (ATL).
This decision propels the drug forward as the first EZH1/2 dual inhibitor to receive regulatory approval, representing an important advancement for treatment of patients beyond intensive chemotherapy.
Japan’s health regulators granted their approval based on a single-arm Phase 2 trial carried out in 25 Japanese patients with three different subtypes of ATL. The drug shrank tumours in 48% of patients, including 20% of patients who had no sign of cancer after treatment.
“We are proud to have successfully translated the science behind dual EZH1 and EZH2 inhibition into a new and novel therapy for these patients, who face a poor prognosis and represent one of the most significant unmet medical needs in Japan,” said Wataru Takasaki, Executive Officer and Head of R&D Division in Japan, Daiichi Sankyo. "We will continue to pioneer the approach in the global development of EZHARMIA, our fifth new oncology medicine approved in Japan in the past three years.”
Daiichi Sankyo notes that approximately 3,000 new cases of ATL are diagnosed each year worldwide, and in Japan, there are approximately 1,000 new ATL cases and 1,000 deaths due to the condition annually.
The company is additionally targeting the wider market in both geographical terms and use indications for Ezharmia by running a global registrational Phase 2 study testing the drug for previously treated peripheral T-cell lymphoma, including ATL.