New J Code for Enhertu Effective July 1, 2020
NEW J CODE for Enhertu (fam-trastuzumab deruxtecan-nxki) effective July 1, 2020
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.
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
ENHERTU has a Boxed WARNING for Interstitial Lung Disease (ILD)/Pneumonitis and Embryo-Fetal Toxicity. Please see Important Safety Information.
Phase 3 trials examining the efficacy and safety of ENHERTU are currently underway.2
The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) includes fam-trastuzumab deruxtecan-nxki (ENHERTU®) as a Category 2A recommendation.