Development strategy of ENHERTU<sup>Ⓡ</sup>（trastuzumab deruxtecan）—anti-HER2 antibody–drug conjugate—

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  • Nakada Takashi
    Oncology Research Laboratories I, R&D Division, Daiichi Sankyo Co., Ltd.
  • Nishimoto Norihiro
    Formulation Technology Research Laboratories, Pharmaceutical Technology Division, Daiichi Sankyo Co., Ltd.
  • Arai Ayako
    Oncology Medical Science Department, Medical Affairs Division, Daiichi Sankyo Co., Ltd.
  • Kuroki Daisuke
    Oncology Medical Science Department, Medical Affairs Division, Daiichi Sankyo Co., Ltd.

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Other Title
  • エンハーツ<sup>Ⓡ</sup> （トラスツズマブ デルクステカン）の開発経緯—抗HER2抗体薬物複合体—

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Description

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.

Journal

  • Drug Delivery System

    Drug Delivery System 36 (5), 384-388, 2021-11-25

    THE JAPAN SOCIETY OF DRUG DELIVERY SYSTEM

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