ENHERTU® Supplemental NDA Submitted in Japan for Patients with HER2 Low/ultralow Metastatic Breast Cancer
“This submission builds on the current HER2 low indication and if approved will provide the opportunity for the earlier use of ENHERTU for patients with HER2 low expression as well as expanding into the HER2 ultralow patient population,” said Toshinori Agatsuma, PhD, Executive Officer, Head of R&D Division in Japan, Daiichi Sankyo. “The DESTINY-Breast06 results represent the first time a HER2 directed therapy has shown a clinically meaningful benefit in these patient populations and we look forward to working with regulatory authorities in Japan to bring ENHERTU to these patients.”
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