In 2019, the FDA Oncology Center of Excellence (OCE) approved 11 new drugs and biologic agents, 30 supplemental drug and biologic applications, and four biosimilar applications in oncology. These included two landmark approvals involving collaboration among international regulators as part of OCE Project Orbis, as well as the approval of three novel antibody–drug conjugates.

中文翻译：

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2019年批准：国际审查和新的不可知分子实体。

在2019年，FDA肿瘤学卓越中心（OCE）批准了11种新药和生物制剂，30种补充药物和生物制剂的应用以及四种生物仿制药在肿瘤学中的应用。其中包括两项具有里程碑意义的批准，涉及作为OCE Project Orbis项目一部分的国际监管机构之间的合作，以及批准了三种新型抗体-药物偶联物。