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  • Enhertu lands in Korea...hopes rise for indication extension
  • by | translator Alice Kang | Sep 21, 2022 05:47am
50,000 people had petitioned for its expedited approval
Approved as a third-line treatment for HER2-positive breast and gastric cancer
Hopes rise for the indication to be extended to second-line in HER2-positive cancer, and HER2-low cancer

The new breast cancer drug Enhertu (trastuzumab deruxtecan), which 50,000 people had petitioned for expedited approval, has finally landed in Korea.

The Ministry of Food and Drug Safety announced on the 19th that it had granted marketing approval for Enhertu, the HER2-directed antibody-drug conjugate (ADC) that was jointly developed by AstraZeneca and Daiichi Sankyo.

With the approval, Enhertu can be used in Korea for the treatment of ¡ãunresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens (third-line or higher treatment) ¡ãlocally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received two or more
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