Posted by Michael Wonder on 04 Oct 2024
Enhertu supplemental new drug application submitted in Japan for patients with HER2 low or HER2 ultra-low metastatic breast cancer
4 October 2024 - Submission based on DESTINY-Breast06 phase 3 trial results that showed Enhertu demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared to standard of care chemotherapy.
Daiichi Sankyo today announced that it has submitted a supplemental new drug application to Japan’s MHLW for Enhertu (trastuzumab deruxtecan) for the treatment of adult patients with HER2 low (IHC 1+ or IHC 2+/ISH-) or ultra-low (IHC 0 with membrane staining) unresectable or recurrent breast cancer.
