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