What is the generic name?

FAM-TRASTUZUMAB DERUXTECAN-NXKI

What is the Trade Name for FAM-TRASTUZUMAB DERUXTECAN-NXKI?

Enhertu

What are the Indications for FAM-TRASTUZUMAB DERUXTECAN-NXKI?

• 1 INDICATIONS AND USAGE ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of: adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. ( 1.1 ) This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. ( 1.1 , 14.1 ) adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen. ( 1.2 ) 1.1 Metastatic Breast Cancer ENHERTU is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. This indication is approved under accelerated approval based on tumor response rate and duration of response [see Clinical Studies (14.1) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. 1.2 Locally Advanced or Metastatic Gastric Cancer ENHERTU is indicated for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.

References: https://open.fda.gov/