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Recently, Daiichi Sankyo announced that its drug Ezharmia (valemetostat tosilate) has been approved by Japan's Ministry of Health, Labor and Welfare (MHLW) for the treatment of relapsed/refractory (r/r) adult T-cell lymphoma (ATL
).
This approval is the world's first EZH1/2 dual inhibitor to be approved for regulatory approval, and it is also the first three cancer drugs
approved in Japan in the past three years.
Pharmacological mechanism of Valemettostat (image source: reference [2])
Pharmacological mechanism of Valemettostat (image source: reference [2]) Ezharmia is a dual inhibitor
of EZH1/2.
Valemetostat clinical trial results (Source: Reference[2])
Valemetostat clinical trial results (Source: Reference[2]) MHLW approved Ezharmia primarily based on the VALENTINE-PTCL01 global critical Phase 2 trial
.
In 25 patients with three different subtypes of relapsed/refractory ATL, the objective response rate (ORR) (primary endpoint of the trial) as tested by an independent efficacy review committee reached 48% (95% CI: 27.
Valemetostat clinical trial results (Source: Reference[2])
Valemetostat clinical trial results (Source: Reference[2]) Ezharmia also demonstrated good tolerance
in this Phase 2 clinical trial.
"As the world's first regulatory-approved dual inhibitor of EZH1/2, Ezharmia represents an important advance in the treatment of patients with relapsed/refractory ATL, where there were few treatment options other than intensive chemotherapy," said Dr.
Resources:
Resources:[1] EZHARMIA® Approved in Japan as First Dual EZH1 and EZH2 Inhibitor Therapyfor Patients with Adult T-Cell Leukemia/Lymphoma.
[1] EZHARMIA® Approved in Japan as First Dual EZH1 and EZH2 Inhibitor Therapyfor Patients with Adult T-Cell Leukemia/Lymphoma.
[2] RD Day 2021 (daiichisankyo.
com).
Retrieved September 27, 2022 from
