Enhertu plus pertuzumab supplemental new drug application submitted in Japan as first-line therapy for patients with HER2 positive metastatic breast cancer

Daiichi Sankyo

7 October 2025 - Submission based on DESTINY-Breast09 Phase 3 trial results that showed Enhertu plus pertuzumab reduced the risk of disease progression or death by 44% versus a taxane, trastuzumab and pertuzumab with a median progression-free survival of greater than three years.

Daiichi Sankyo has submitted a supplemental new drug application to Japan’s MHLW for Enhertu (trastuzumab deruxtecan) in combination with pertuzumab for the treatment of patients with HER2 positive unresectable or recurrent breast cancer.

Read Daiichi Sankyo press release

Michael Wonder

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Michael Wonder