(Zooms out to show full ENHERTU molecule. The monoclonal antibody consists of the same amino acid sequence as trastuzumab and targets HER2-expressing tumors. (TEXT ON SCREEN: HER2-directed monoclonal antibody Potent cytotoxic agent Tumor-selective cleavable linker.) (The individual parts of ENHERTU are zoomed in on, pointed at, and labeled on screen.)ĮNHERTU is composed of a HER2-directed monoclonal antibody and a potent topoisomerase I inhibitor payload attached by a tumor-selective cleavable linker. (TEXT ON SCREEN: ENHERTU logo and ENHERTU Molecule)īuilt upon the foundation established by earlier anti-HER2 treatments, ENHERTU is a HER2-directed ADC that provides targeted delivery of a cytotoxic agent. Please see the Important Safety Information at the end of this video and full Prescribing Information, including Boxed WARNINGS, and Medication Guide at .) Refer to the full Prescribing Information for more information. Please see the Important Safety Information included at the end of this video. Advise patients of these risks and the need for effective contraception. Exposure to ENHERTU during pregnancy can cause embryo-fetal harm. Advise patients of the risk and to immediately report symptoms. Permanently discontinue ENHERTU in all patients with Grade 2 or higher ILD or pneumonitis. Monitor for and promptly investigate signs and symptoms including cough, dyspnea, fever, and other new or worsening respiratory symptoms. Interstitial lung disease and pneumonitis, including fatal cases, have been reported with ENHERTU. And locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen.ĮNHERTU has Boxed WARNINGS for interstitial lung disease, or ILD, and embryo-fetal toxicity. Locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen)ĮNHERTU (fam-trastuzumab deruxtecan-nxki) is a specifically engineered, HER2-directed antibody-drug conjugate, or ADC, indicated for the treatment of adult patients in two tumor types: 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 six months of completing therapy. In the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy.Unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either: (TEXT ON SCREEN: ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with: Camera proceeds to zoom out and show entire molecule as voiceover of the indications and black boxed WARNINGS are voiced over.) The camera slowly zooms in to ultra-close up as the molecule rotates. (Enlarged ENHERTU molecule in 3-dimensional animation to show the molecule in close-up. (LOGO: ENHERTU ® (fam-trastuzumab deruxtecan-nxki) 20 mg / mL injection for intravenous use.)
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