Development strategy of ENHERTU^Ⓡ（trastuzumab deruxtecan）—anti-HER2 antibody–drug conjugate—

Abstract

Antibody-drug conjugate（ADC） represents a promising class of pharmaceutical with a wide therapeutic index due to highly efficient and selective drug delivery. We have developed a novel drug-linker technology with a potent camptothecin derivative. Using this technology, we generated a new anti-HER2 ADC named trastuzumab deruxtecan（T-DXd）. We stably supply of this drug by performing high level quality control on complex constituents as antibody, drug-linker, and both by selecting formulation, forms, vials, and packing. T-DXd was approved for breast cancer and gastric cancer with HER2 expression, as a new treatment option. However, it is necessary to use it while carefully monitoring side effects such as interstitial lung disease and so on in clinical settings.