The personalized medicine is in a rapidly evolving scenario. The identification of actionable mutations is revolutionizing the therapeutic landscape of tumors. The morphological and histological tumor features are enriched by the extensive genomic profiling, and the first tumor-agnostic drugs have been approved regardless of tumor histology, guided by predictive and druggable genetic alterations. This new paradigm of “mutational oncology”, presents a great potential to change the oncologic therapeutic scenario, but also some critical aspects need to be underlined. A process governance is mandatory to ensure the genomic testing accuracy and homogeneity, the economic sustainability, and the regulatory issues, ultimately granting the possibility of translating this model in the “real world”.

In this position paper, based on experts’ opinion, the AIOM–SIAPEC-IAP–SIBIOC–SIF Italian Scientific Societies revised the new agnostic biomarkers, the diagnostic technologies available, the current availability of agnostic drugs and their present indication.

个性化医疗正处于一个快速发展的场景中。可操作突变的识别正在彻底改变肿瘤的治疗前景。广泛的基因组分析丰富了肿瘤的形态学和组织学特征，并且在预测性和可药物遗传改变的指导下，第一个与肿瘤无关的药物已被批准，无论肿瘤组织学如何。这种“突变肿瘤学”的新范式具有改变肿瘤治疗方案的巨大潜力，但也需要强调一些关键方面。流程治理是强制性的，以确保基因组测试的准确性和同质性、经济可持续性和监管问题，最终赋予在“现实世界”中转换该模型的可能性。

在这份立场文件中，根据专家的意见，AIOM-SIAPEC-IAP-SIBIOC-SIF 意大利科学学会修订了新的不可知生物标志物、可用的诊断技术、不可知药物的当前可用性及其目前的适应症。