ADC (抗体-薬物複合体) への注目
Spotlight on Antibody-Drug Conjugates
|出版日||ページ情報||英文 71 Pages
|ADC (抗体-薬物複合体) への注目 Spotlight on Antibody-Drug Conjugates|
|出版日: 2019年09月20日||ページ情報: 英文 71 Pages||
当レポートでは、ADC (抗体-薬物複合体) 市場について調査し、市場の概要、主要企業、主な承認済みADC、パイプライン動向、および戦略などについて分析しています。
The first antibody-drug conjugate (ADC), Mylotarg, reached the market almost two decades ago. Since this time, the ADC field has undergone slow but transformative enhancements, with improvements to technologies and advancements in the pipeline leading to an invigoration of the field. The past couple of years have seen the approvals of three new ADCs: Polivy, Lumoxiti, and Besponsa, increasing the total number of ADCs approved by regulators worldwide to six. These approvals mark the start of a new era in which the ADC field is finally beginning to realize its full potential. With the ADC pipeline swelling to around 250 novel candidates in various stages of preclinical and clinical development, approvals for more ADCs appear firmly on the horizon.
ADC development has historically not been without its setbacks. While the concept of delivering a potent cytotoxic payload directly to tumor cells and causing minimum damage to non-tumor cells was viewed as a significant advance towards precision medicine, the concept has proved difficult to translate into the clinic. Despite the obvious conceptual advantages to ADCs, toxicity, including accumulation during long treatment durations, can still be challenging. Arguably the greatest setback related to toxicity for the ADC class was Mylotarg's withdrawal from the US market in
2010. Although US approval was reinstated in 2017, at a reduced dose and a revised fractionated dosing schedule, the withdrawal has up until relatively recently cast a shadow over the class. However, based on recent approvals and the robust pipeline, it is clear that the clouds are lifting for the ADC class.
The recent resurgence in ADC development coincides with improvements in ADC platforms, linker technologies, and new applications such as combination approaches with immunotherapy and chemotherapy to treat cancer. There is also a small but emerging trend to evaluate ADCs beyond the realm of oncology. The late-stage ADC pipeline is still, however, solely focused on oncology, specifically solid tumor indications.