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  • Enhertu seeks approval as 2nd-line tx in breast cancer
  • by Eo, Yun-Ho | translator Alice Kang | Dec 8, 2022 06:05am
next-generation ADC Enhertu
Applied for approval to MFDS and is being reviewed
Expected to be approved in Q1 2023 at the earliest
The antibody-drug conjugate anticancer drug ¡®Enhertu¡¯ is attempting to extend its indication to the second line in breast cancer.

According to industry sources, the Ministry of Food and Drug Safety is currently reviewing whether to expand the indication for the ADC drug Enhertu (trastuzumab deruxtecan). Its approval is expected in Q1 next year (2023) at the earliest.

The indication extension is to treat adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within 6 months of completing therapy.

The drug has been a
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