Jan 6, 2020: Daiichi Sankyo Company ltd announced that ENHERTU® (trastuzumab deruxtecan), a HER2 directed antibody drug conjugate, is now available by prescription in the U.S. ENHERTU was granted the accelerated approval by the U.S. Food and Drug Administration (FDA) on December 20, 2019 for the treatment of adult patients dealing 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 below the accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon the verification and description of clinical benefit in a confirmatory trial.
ENHERTU is approved with a Boxed WARNING for the Interstitial Lung Disease (ILD)/pneumonitis and Embryo-Fetal Toxicity.
The safety of ENHERTU has been evaluated in a pooled analysis of 234 patients with the unresectable or metastatic HER2 positive breast cancer who received at least one dose of 5.4 mg/kg ENHERTU in the DESTINY-Breast01 trial and a phase 1 trial. https://www.daiichisankyo.com/media_investors/media_relations/press_releases/detail/007092.html
