Japan Approves Daiichi Sankyo's ENHERTU® for HER2-Positive Cancers Using AI-Driven Real-World Evidence

Japan's Ministry of Health, Labour and Welfare (MHLW) has approved Daiichi Sankyo's ENHERTU® for treating HER2-positive advanced or recurrent solid cancers. The decision was supported by real-world evidence generated through Guardant Health's InfinityAI platform. This marks a significant step in using data-driven insights to complement traditional clinical trials.

The approval covers five cancer types: breast, stomach, lung, bladder, and cervical cancers. Guardant Health, a precision oncology company, worked with Daiichi Sankyo to analyse outcomes from patients with HER2 amplifications detected via its Guardant360® test. Guardant Health and Daiichi Sankyo examined data from a large group of patients with HER2 amplifications. Their findings highlighted a substantial unmet medical need across multiple tumour types. While HER2 amplification is well understood in breast cancer, identifying patients and gathering evidence remains difficult, particularly in rare biomarker-defined populations.

The companies combined real-world evidence from Guardant's InfinityAI platform with clinical trial data to strengthen Daiichi Sankyo's MHLW application. InfinityAI, an AI and machine learning system, specialises in generating real-world evidence to improve cancer care at every stage—from screening to treatment selection.

Helmy Eltoukhy, Guardant Health's chairman and co-CEO, noted that the approval demonstrates the increasing importance of real-world evidence in precision oncology. He also emphasised its potential to create new regulatory pathways for rare biomarker-defined patient groups.

This collaboration shows how high-quality real-world evidence can work alongside clinical data to support drug approvals in specific genomic subpopulations. Guardant's tests and AI-driven insights aim to enhance outcomes by providing deeper, data-backed understanding of cancer treatments. The MHLW approval of ENHERTU® in Japan relied on both clinical trials and real-world evidence from Guardant Health's InfinityAI. The decision expands treatment options for patients with HER2-positive cancers across five tumour types.

Guardant Health continues to focus on advancing precision oncology through data-driven solutions. The partnership with Daiichi Sankyo highlights how real-world evidence can shape regulatory decisions and improve access to targeted therapies.