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HER2-directed ADC ¡®Enhertu¡¯ in process of seeking approval

By Eo, Yun-Ho | translator Alice Kang

21.05.11 15:43:47

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Approved for breast and gastric cancer indication in the U.S ¡¦is preparing for approval in Korea

Demonstrated efficacy in gastric cancer in the Phase II DESTINY-Gastric01 trial


A HER2-directed antibody-drug conjugate (ADC) is looking to enter the Korean market.

According to industry officials, AstraZeneca Korea and Daiichi Sankyo Korea are preparing the application process for the approval of their human epidermal growth factor receptor 2 (HER2)-directed antibody-drug conjugate (ADC) ¡®Enhertu (trastuzumab deruxtecan).¡¯

Enhertu, which has indications for breast and gastric cancer, was jointly developed by AstraZeneca and Daiichi Sankyo and was first approved for the treatment of recurrent metastatic HER-positive breast cancer in the U.S. in 2019.

Last year, Enhertu was additionally approved in the U.S. for the treatment of locally advanced or m

Eo, Yun-Ho(unkindfish@dailypharm.com)
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