JAPAN — The Japanese Ministry of Health, Labor, and Welfare (MHLW) has approved Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) for the treatment of adults with HER2-positive unresectable or recurrent breast cancer.
The treatment, which includes trastuzumab and a taxane, is indicated for use in such patients following previous chemotherapy.
HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors including breast, gastric, lung, and colorectal cancers.
HER2 protein overexpression may occur as a result of HER2 gene amplification and is often associated with aggressive disease and poor prognosis in breast cancer.
The approval by Japan’s Ministry of Health, Labour and Welfare (MHLW) was based on the results of the DESTINY-Breast03 trial where ENHERTU demonstrated a 72% reduction in the risk of disease progression or death compared to trastuzumab emtansine (T-DM1).
An antibody-drug conjugate (ADC), Enhertu comprises a HER2 monoclonal antibody linked to topoisomerase I inhibitor payload through a stable tetrapeptide-based cleavable linker.
The safety profile of ENHERTU in DESTINY-Breast03 was consistent with previous clinical trials with no new safety concerns identified.
The most common adverse reactions included nausea, fatigue, vomiting, decreased neutrophil count, alopecia, anemia, and decreased leucocyte count, according to the company’s press release.
The antibody-drug conjugate raked in 48.2 billion yen (US$346.5 million) in the company’s second fiscal quarter ending in September and 31.3 billion yen (US$225 million) in the first, with two new approvals in August.
Outside breast cancer, Enhertu in August became the first drug specifically approved for HER2-mutant non-small cell lung cancer.
While Daiichi Sankyo has been concentrating on antibody-drug conjugates, the Japanese company has achieved a global first in an area that Pfizer is also interested in.
Ezharmia, or valemetostat (DS-3201), has been approved in Japan by Daiichi Sankyo for the treatment of relapsed or refractory adult T-cell leukemia/lymphoma (ATL).
With this approval, Ezharmia becomes the first Enhancer of Zeste 1/2 (EZH1/2) dual inhibitor to receive regulatory approval anywhere in the world.
Back in 2020, Epizyme’s Tazverik became the first FDA-approved EZH2 inhibitor thanks to an accelerated approval in epithelioid sarcoma.
Besides Epizyme, Pfizer a few days ago unveiled early data for its investigational EZH2 candidate, PF-06821497, in follicular lymphoma and prostate cancer.
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