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2022-09-26| Trials & Approvals

Daiichi Sankyo Wins Approval For Cancer Treatment in Japan

by Max Heirich
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Daiichi Sankyo announced the approval of the EZHARMIA® (valemetostat tosilate) by the Japan Ministry of Health, Labor and Welfare (MHLW). EZHARMIA is a dual inhibitor treating patients with relapsed or refractory adult T-cell leukemia/lymphoma (ATL). The basis of the approval for the cancer treatment was a Phase 2 Study evaluating the treatment’s efficacy and safety.

Related Article: CHMP Gives Kite’s Lymphoma Immunotherapy a Positive Opinion

The Dual Inhibitor of Cancer

Enhancer of zeste homolog 1(EZH1) and enhancer of zeste homolog 2 (EZH2) are enzymes in the polycomb protein complex. EZH1 mediates histone methylation, while EZH2 provides the instructions for making histone methylation. However, researchers have noted that these enzymes’ overexpression is coupled with certain types of cancer. Specifically, changes in EZH2 impair cells’ ability to divide properly. This results in prostate, breast, and other body parts cancerous tumors.

Recent studies have explored the possibility of using EZH2 inhibition as a cancer treatment. . Recently, Pfizer presented promising data for PF-06821497, a EZH2 inhibitor targeting small lung and prostate cancer. However, while Pfizer’s candidate is still in its first Phase, EZHARMIA already completed its Phase 2 trial

EZHARMIA received an Orphan Drug Designation (ODD) from the United States Food and Drug Administration (FDA) for the treatment of PTCL in December 2021. In addition, Japan’s MHLW gave the treatment the same designation in November 2021. However, the MHLW beat the FDA in granting EZHARMIA approval. 

Approved off the Back of a Phase 2 Trial

A Phase 2 trial evaluated the safety and efficacy of EZHARMIA as a daily monotherapy in patients with relapsed/refractory ATL previously treated with mogamulizumab. The primary endpoint was an objective response rate (ORR) assessed by an independent efficacy assessment committee. EZHARMIA achieved an ORR of 48%, meeting the assessment criteria.

On the approval, Wataru Takasaki, PhD, Executive Officer, Head of R&D Division in Japan at Daiichi Sankyo, said, “As the first dual inhibitor of EZH1 and EZH2 to receive regulatory approval anywhere in the world, EZHARMIA represents an important advancement in the treatment of patients with relapsed or refractory adult T-cell leukemia/lymphoma, who have very few options beyond intensive chemotherapy.”

It is currently unknown whether EZHARMIA will advance to a Phase 3 clinical trial. However, Japan’s approval for cancer treatment has doubtlessly strengthened Daiichi Sankyo’s case for eventual approval by other regulatory bodies. 

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