Daiichi Sankyo and AstraZeneca are excited to announce that ENHERTU® (fam-trastuzumab deruxtecan-nxki) is now approved for a new indication.
ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate that was recently approved for use in adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.1
ENHERTU has Boxed WARNINGS for Interstitial Lung Disease/Pneumonitis and Embryo-Fetal Toxicity. Please see the Important Safety Information below and the full Prescribing Information, including Boxed WARNINGS, and Medication Guide.
RECOMMENDED DOSAGE FOR LOCALLY ADVANCED OR METASTATIC GASTRIC CANCER
The recommended dosage of ENHERTU for locally advanced or metastatic gastric and GEJ cancer is 6.4 mg/kg given as an intravenous infusion once every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity. Please see the full Prescribing Information for details on dose reductions and modifications.
PATIENT SELECTION CONSIDERATIONS
Select patients with locally advanced or metastatic gastric cancer based on HER2 protein overexpression or HER2 gene amplification. Reassess HER2 status if it is feasible to obtain a new tumor specimen after prior trastuzumab-based therapy and before treatment with ENHERTU.
ENHERTU4U ICD-10 CODES
Please update your organization’s systems to include relevant ICD-10 codes for gastric cancer. The ENHERTU4U website lists codes for your consideration: https://www.enhertu4u.com/hcp/coding-and-reimbursement.html
ENHERTU PACKAGE INFORMATION
One 100 mg single-dose vial
Important Safety Information
ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen.