Japan Approves ENHERTU® for HER2-Positive Cancers Using AI-Driven Real-World Evidence

A new approval for the cancer drug ENHERTU® in Japan has relied on both clinical trials and real-world evidence. Daiichi Sankyo worked with Guardant Health to analyse data from patients with HER2-positive cancers, covering eight distinct tumour types. The collaboration marks a significant step in using advanced analytics to support regulatory decisions. The Japanese Ministry of Health, Labour and Welfare (MHLW) approved ENHERTU® for treating HER2-positive advanced or recurrent solid cancers. This decision included eight cancer types: breast, stomach, lung (NSCLC), bladder, cervical, ovarian, endometrial, and thyroid. While HER2 amplification is well understood in breast cancer, identifying patients in other tumour types remains difficult.

Guardant Health, a precision oncology company founded in 2012, provided real-world evidence through its InfinityAI platform. This AI-driven system analyses data from Guardant360®, a comprehensive blood and tissue test. By examining outcomes from a large patient cohort, the companies demonstrated unmet clinical needs across multiple HER2-positive cancers.

Daiichi Sankyo used this real-world evidence alongside clinical trial data to strengthen its MHLW application. Helmy Eltoukhy, Guardant Health's chairman and co-CEO, noted that the approval underscores the increasing importance of real-world data in precision oncology. Such evidence could open new regulatory pathways, particularly for rare biomarker-defined patient groups. The approval of ENHERTU® in Japan expands treatment options for patients with HER2-positive cancers. By combining clinical trials with real-world evidence, the decision reflects a broader shift in how regulators assess therapies. Guardant Health's AI platform played a key role in analysing patient outcomes, reinforcing the value of data-driven insights in cancer care.